scholarly journals The Efficacy of Single-Dose versus Double-Dose Praziquantel Treatments onSchistosoma mansoniInfections: Its Implication on Undernutrition and Anaemia among Primary Schoolchildren in Two On-Shore Communities, Northwestern Tanzania

2017 ◽  
Vol 2017 ◽  
pp. 1-13 ◽  
Author(s):  
David Z. Munisi ◽  
Joram Buza ◽  
Emmanuel A. Mpolya ◽  
Teckla Angelo ◽  
Safari M. Kinung’hi
Keyword(s):  
Single Dose ◽  
Geometric Mean ◽  
Reduction Rate ◽  
Repeated Dose ◽  
Cure Rate ◽  
Treatment Regimens ◽  
Northwestern Tanzania ◽  
Primary Schoolchildren ◽  
The Mean ◽  
To Receive

Administering more than one treatment may increase Praziquantel cure and egg reduction rates, thereby hastening achievement of schistosomiasis transmission control. A total of 431S. mansoni-infected schoolchildren were randomized to receive either a single or repeated 40 mg/kg Praziquantel dose. Heights, weights, and haemoglobin levels were determined using a stadiometer, weighing scale, and HemoCue, respectively. At 8 weeks, cure rate was higher on repeated dose (93.10%) compared to single dose (68.68%) (p<0.001). The egg reduction rate was higher on repeated dose (97.54%) compared to single dose (87.27%) (p=0.0062). Geometric mean egg intensity was lower among those on repeated dose (1.30 epg) compared to single dose (3.18 epg) (p=0.036) but not at 5 (p>0.05) and 8 (p>0.05) months with no difference in reinfection rate. No difference in the prevalence of stunting was observed between the two treatment regimens (p>0.05) at 8 months, but there was an increase in the prevalence of wasting among those on repeated dose (p<0.001). There was an increase in the mean haemoglobin levels at 8 months with no difference between the two arms (p>0.05). To achieve reduction of transmission intensity and disease control in highly endemic areas, repeated treatments alone may not be sufficient. This trial was registered withPACTR201601001416338.

scholarly journals Two or Three Consecutive Days Albendazole Treatment Has Better Efficacy than Single-Dose Albendazole Treatment for Trichuriasis

2020 ◽  
Vol 12 (1) ◽  
pp. 45-50
Author(s):  
Dina Evalina Gultom ◽  
Muhammad Ali ◽  
Ayodhia Pitaloka Pasaribu ◽  
Syahril Pasaribu
Keyword(s):  
Single Dose ◽  
Reduction Rate ◽  
Primary School Children ◽  
Repeated Dose ◽  
Hookworm Infection ◽  
Cure Rate ◽  
Chi Square ◽  
Group Iii ◽  
Group I ◽  
Stool Samples

BACKGROUND: Soil-transmitted helminth (STH) infection is endemic in Indonesia. Singledose albendazole is routinely used to control STH infections. Some studies found that repeated-dose of albendazole showed better efficacy. There is no study in Indonesia to compare single-dose and repeated-dose albendazole for against STH infections.METHODS: A randomized, open clinical trial was conducted in July-September 2018 among primary school children. Stool samples were collected before treatment and on day 7, 14, 21, and 28 after treatment then stained using the Kato-Katz method. Group I received three consecutive days, group II received two consecutive days, and Group III received single-dose of albendazole. Cure rate (CR) and egg reduction rate (ERR) were compared using Chi-square tests, and eggs per gram (EPG) was compared using the Kruskal Wallis test (p<0.05).RESULTS: One hundred ninety-five subjects enrolled and divided into 65 subjects in each group. The CR and ERR of trichuriasis after three consecutive days (79.5% and 97.4%) and two consecutive days regimen (70.3% and 91.9%) were higher than single-dose regimen (32.2% and 74.6%) with p<0.001, but not for ascariasis or hookworm infection. The highest efficacy was found in three consecutive days regimen group. Trichuris trichiura EPG was significantly different among the three groups on day 7, 14, 21, and 28 after treatment (p<0.001).CONCLUSION: Three and two consecutive days albendazole have better efficacy than single-dose of albendazole for trichuriasis, but not for ascariasis or hookworm infection. Two consecutive days albendazole is better choice for treating trichuriasis with more adherence and less side effect than three consecutive days regimen.KEYWORDS: soil-transmitted helminth infection, albendazole, single-dose, repeated-dose

DMSA-scintigraphy in paediatrics: Is the evaluation of the geometric mean necessary for the calculation of the differential renal function?

2001 ◽  
Vol 40 (04) ◽  
pp. 107-110 ◽  
Author(s):  
B. Roßmüller ◽  
S. Alalp ◽  
S. Fischer ◽  
S. Dresel ◽  
K. Hahn ◽  
...  
Keyword(s):  
Renal Function ◽  
Geometric Mean ◽  
Region Of Interest ◽  
Posterior View ◽  
Renal Abnormality ◽  
Anterior View ◽  
Differential Renal Function ◽  
The Mean ◽  
The Right ◽  
To Receive

SummaryFor assessment of differential renal function (PF) by means of static renal scintigraphy with Tc-99m-dimer-captosuccinic acid (DMSA) the calculation of the geometric mean of counts from the anterior and posterior view is recommended. Aim of this retrospective study was to find out, if the anterior view is necessary to receive an accurate differential renal function by calculating the geometric mean compared to calculating PF using the counts of the posterior view only. Methods: 164 DMSA-scans of 151 children (86 f, 65 m) aged 16 d to 16 a (4.7 ± 3.9 a) were reviewed. The scans were performed using a dual head gamma camera (Picker Prism 2000 XP, low energy ultra high resolution collimator, matrix 256 x 256,300 kcts/view, Zoom: 1.6-2.0). Background corrected values from both kidneys anterior and posterior were obtained. Using region of interest technique PF was calculated using the counts of the dorsal view and compared with the calculated geometric mean [SQR(Ctsdors x Ctsventr]. Results: The differential function of the right kidney was significantly less when compared to the calculation of the geometric mean (p<0.01). The mean difference between the PFgeom and the PFdors was 1.5 ± 1.4%. A difference > 5% (5.0-9.5%) was obtained in only 6/164 scans (3.7%). Three of 6 patients presented with an underestimated PFdors due to dystopic kidneys on the left side in 2 patients and on the right side in one patient. The other 3 patients with a difference >5% did not show any renal abnormality. Conclusion: The calculation of the PF from the posterior view only will give an underestimated value of the right kidney compared to the calculation of the geometric mean. This effect is not relevant for the calculation of the differntial renal function in orthotopic kidneys, so that in these cases the anterior view is not necesssary. However, geometric mean calculation to obtain reliable values for differential renal function should be applied in cases with an obvious anatomical abnormality.

scholarly journals Efficacy of a Single Dose versus Triple Dose Regimen of Mebendazole against Hookworm Infection among School Children: A Randomized, Single blinded Trial.

2019 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
Reduction Rate ◽  
Secondary Outcome ◽  
Hookworm Infection ◽  
Cure Rate ◽  
School Aged Children ◽  
Egg Reduction Rate ◽  
Triple Dose

Abstract Background: The current control efforts against soil transmitted helminthic infection focused on reducing morbidity and transmission potential through periodic anthelminthic chemotherapy of single dose of mebendazole and albendazole regimen. Single dose mebendazole is one of extensively applicable drug regimen as a preventive chemotherapy in hookworm endemic areas. However, nowadays, studies reveal single dose treatment regimen has poor and unsatisfactory efficacy status against hookworm infection. We evaluated the efficacy status of single dose (500mg) versus triple dose (100mg) of mebendazole against hookworm infection among school aged children.Methods: This randomized, single-blinded clinical trial took place in a primary school on Burie and Debre Elias towns, Northwest Ethiopia among school-aged children (6-14). Using simple randomization, eligible hookworm positive children were randomly allocated (1:1) to either a single dose or triple dose of mebendazole arm. Stool samples were collected at baseline and follow-up period (14-21 days after treatment) for McMaster analysis. The primary and secondary outcome measures in this study were cure rate (CR) and egg reduction rate (ERR), respectively. Results were displayed using tables and figure. Independent t test was used to compare group means, logistic regression was used to calculate odds ratio (OR), and P-value < 0.05 at 95% CI was considered for statistical significance.Result: 109 children were allocated for each treatment arm and 103 children were completed the drug efficacy follow up study. Cure rate against hookworm was significantly higher in triple dose (96.1%) than in single dose (30.8%) with (OR=55.125; 95% CI: 11.92-254.9; P < 0.001). Egg reduction rate against hookworm infection in triple dose (99.5%) was also significantly higher than single dose (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.Conclusion: Single dose regimen of mebendazole for the treatment of hookworm infection showed poor efficacy, while triple dose revealed satisfactory efficacy. Therefore, we recommend for giving special emphasis on current deworming program which implemented through single dose mebendazole for hookworm endemic area.

Efficacy of a Single dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections among School Children: A Randomized Single-Blinded Trial

2020 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
Multiple Dose ◽  
Reduction Rate ◽  
Infection Intensity ◽  
Cure Rate ◽  
Preventive Chemotherapy ◽  
School Aged Children ◽  
Multiple Dose Regimen ◽  
Hookworm Infections

Abstract Background : Despite the existence of population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, Hookworm disease transmissions remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study evaluated the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against Hookworm infections among school aged children. Methods : This randomized single-blinded clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible Hookworm positive children were allocated (1:1) to either a single or multiple doses treatment arm. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Main outcome measures : The cure rate against Hookworm and egg reduction rate for determining the changes in infection intensity were the main outcome measures after 14-21 days following dosing. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant. Result: 109 children were participated in both treatment arms. Cure rate against Hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with (OR=55.125; 95% CI: 11.92-254.9; P < 0.001). The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference (t (101) =5.38; 95% CI 230.95-505.36; P < 0.001). Conclusion : The single dose regimen of mebendazole for the treatment of Hookworm infection showed poor efficacy, while the multiple dose revealed satisfactory efficacy. Moreover, infection intensity reduction was not achieved following single dosing. Therefore, we strongly recommend replacing the single dose mebendazole regimen with multiple dose regimen during deworming program in hookworm endemic areas. Trial registration : This trial is registered in www.pactr.org , # PACTR201911466695052

scholarly journals Treatment of intestinal helminthiasis: mebendazole only or mebendazole-pyrantel pamoate?

2007 ◽  
Vol 47 (5) ◽  
pp. 216
Author(s):  
Wisman Dalimunthe ◽  
Charles Siregar ◽  
Munar Lubis ◽  
Syahril Pasaribu ◽  
Chairuddin P. Lubis
Keyword(s):  
Single Dose ◽  
Negative Impact ◽  
Reduction Rate ◽  
Multiple Infections ◽  
Cure Rate ◽  
School Students ◽  
Pyrantel Pamoate ◽  
Significant Difference ◽  
Chi Squared ◽  
Egg Reduction Rate

Background Although intestinal helminthiasis causes highmorbidity and has a negative impact on children’s growth anddevelopment, the efficacy of antihelmintics for multiplehelminthiasis in mass treatment is still doubtful.Objective To compare the efficacy of single dose mebendazoleand a combination of pyrantel pamoate and mebendazole for thetreatment of multiple infections due to Ascaris lumbricoides,hookworm, and Trichuris trichiura.Methods Subjects were elementary school students in Suka Village,Tiga Panah subdistrict, North Sumatera. They were randomizedto either receive mebendazole (M Group) or mebendazole-pyrantel pamoate group (MP Group). Stool examinations wereperfomed on each subjects on day 7, 14, 21, and 28 after treatment.Analyses were perfomed by using chi-squared and Mann-WhitneyU tests.Results The prevalence of intestinal helminthiasis was 95.4%. T.trichiura (88.7%) was the most common cause of infection followedby A. lumbricoides (79.5%), and hookworm (3.1%). Two hundredthirty nine (76.8%) children had multiple infections. Althoughthe egg reduction rate of intestinal helminthiasis in thecombination group was faster than that of the mebendazole group,there was no significant difference in the cure rate of both groups.Conclusion A single dose of mebendazole is preferred for masstreatment of multiple intestinal helminthiasis infections.

scholarly journals Quadrivalent Meningococcal Vaccination of Adults: Phase III Comparison of an Investigational Conjugate Vaccine, MenACWY-CRM, with the Licensed Vaccine, Menactra

2009 ◽  
Vol 16 (12) ◽  
pp. 1810-1815 ◽  
Author(s):  
Keith S. Reisinger ◽  
Roger Baxter ◽  
Stanley L. Block ◽  
Jina Shah ◽  
Lisa Bedell ◽  
...  
Keyword(s):  
Single Dose ◽  
Conjugate Vaccine ◽  
Geometric Mean ◽  
Case Fatality ◽  
The United States ◽  
Phase Iii ◽  
Serum Samples ◽  
Serious Adverse Event ◽  
Specific Serum ◽  
To Receive

ABSTRACT Neisseria meningitidis is a leading cause of bacterial meningitis in the United States, with the highest case fatality rates reported for individuals ≥15 years of age. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM197 conjugate vaccine, MenACWY-CRM, to those of the licensed meningococcal conjugate vaccine, Menactra, when administered to healthy adults. In this phase III multicenter study, 1,359 adults 19 to 55 years of age were randomly assigned to one of four groups (1:1:1:1 ratio) to receive a single dose of one of three lots of MenACWY-CRM or a single dose of Menactra. Serum samples obtained at baseline and 1 month postvaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA). The hSBA titers following vaccination with MenACWY-CRM and Menactra were compared in noninferiority and prespecified superiority analyses. Reactogenicity was similar in the MenACWY-CRM and Menactra groups, and neither vaccine was associated with a serious adverse event. When compared with Menactra, MenACWY-CRM met the superiority criteria for the proportions of recipients achieving a seroresponse against serogroups C, W-135, and Y and the proportion of subjects achieving postvaccination titers of ≥1:8 for serogroups C and Y. MenACWY-CRM's immunogenicity was statistically noninferior (the lower limit of the two-sided 95% confidence interval was more than −10%) to that of Menactra for all four serogroups, with the postvaccination hSBA geometric mean titers being consistently higher for MenACWY-CRM than for Menactra. MenACWY-CRM is well tolerated in adults 19 to 55 years of age, with immune responses to each of the serogroups noninferior and, in some cases, statistically superior to those to Menactra.

scholarly journals 1159. Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Pediatric Participants With Confirmed or Suspected Gram-negative Bacterial Infections: A Phase 1b, Open-label, Single-Dose Clinical Trial

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S671-S671
Author(s):  
John S Bradley ◽  
Nataliia Makieieva ◽  
Camilla Tøndel ◽  
Emmanuel Roilides ◽  
Matthew S Kelly ◽  
...  
Keyword(s):  
Single Dose ◽  
Plasma Concentration ◽  
Bacterial Infections ◽  
Geometric Mean ◽  
Complicated Urinary Tract Infection ◽  
Research Support ◽  
Open Label ◽  
Gram Negative ◽  
Age Cohorts ◽  
The Mean

Abstract Background Imipenem/cilastatin/relebactam (IMI/REL) is approved for treating hospital-acquired/ventilator-associated bacterial pneumonia, complicated urinary tract infection, and complicated intra-abdominal infection in adults. This study assessed single-dose pharmacokinetics (PK), safety, and tolerability of IMI/REL in neonatal and pediatric participants with confirmed or suspected gram-negative bacterial infections. Methods This was a phase 1, open-label, non-comparative study (NCT03230916). Age- and weight-adjusted dosing is summarized in Table 1. The primary objective was to characterize the PK profiles for imipenem and relebactam after a single intravenous dose of IMI/REL. PK parameters were analyzed using population modeling. The PK target for imipenem was the percent time of the dosing interval that the unbound plasma concentration exceeded the minimum inhibitory concentration (%fT &gt;MIC) of ≥30% (MIC used, 2 µg/mL). The PK target for relebactam was an area under the curve (AUC)/MIC ratio &gt;8 (MIC used, 2 µg/mL), corresponding to AUC0-24h &gt;58.88 μM∙h. Safety and tolerability were assessed for up to 14 days after drug infusion. Results Of the 46 participants who received IMI/REL, 42 were included in the PK analysis. The mean plasma concentration-time profiles for imipenem and relebactam were generally comparable across age cohorts (Figure). For imipenem, the geometric mean %ƒT &gt;MIC ranged from 50% to 94% and the mean maximum concentration (Cmax) ranged from 65 μM to 126 μM (Table 2). For relebactam, the geometric Cmax ranged from 33 μM to 87 μM and mean AUC0-6h ranged from 51 μM·h to 159 μM·h across the age cohorts (Table 2). IMI/REL was well tolerated with 8 (17.4%) participants experiencing ≥1 adverse events (AE) and 2 (4.3%) participants experiencing AE that were deemed drug related by the investigator. Drug-related AE were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, and diarrhea, which were non-serious, mild in severity, and resolved within the follow-up period of 14 days. Figure 1 Conclusion Imipenem and relebactam exceeded the pediatric plasma PK targets across pediatric age cohorts in the study; the single doses of IMI/REL were well tolerated. These results will inform IMI/REL dose selection for further pediatric clinical evaluation. Disclosures Camilla Tøndel, MD, PhD, Merck & Co., Inc., (Grant/Research Support) Emmanuel Roilides, MD, PhD, FIDSA, FAAM, FESCMID, FECMM, FISAC, Merck Sharp & Dohme Corp. (Consultant, Grant/Research Support) Matthew S. Kelly, MD, MPH, Merck Sharp & Dohme Corp. (Consultant, Grant/Research Support) Munjal Patel, PhD, Merck Sharp & Dohme Corp. (Employee, Shareholder) Pavan Vaddady, PhD, Merck Sharp & Dohme Corp. (Employee) Alok Maniar, MD, MPH, Merck Sharp & Dohme Corp. (Employee, Shareholder) Ying Zhang, PhD, Merck & Co., Inc. (Employee, Shareholder) Amanda Paschke, MD MSCE, Merck Sharp & Dohme Corp. (Employee, Shareholder) Joan R. Butterton, MD, Merck Sharp & Dohme Corp. (Employee, Shareholder) Luke F. Chen, MBBS MPH MBA FRACP FSHEA FIDSA, Merck (Employee)

scholarly journals Efficacy of Mebendazole and Praziquantel against Soil-Transmitted Helminths and Schistosoma mansoni Infections among Schoolchildren in Northwest Ethiopia

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Kefale Ejigu ◽  
Tadesse Hailu ◽  
Megbaru Alemu
Keyword(s):  
Single Dose ◽  
Schistosoma Mansoni ◽  
Reduction Rate ◽  
Northwest Ethiopia ◽  
Cure Rate ◽  
Soil Transmitted Helminths ◽  
Stool Samples ◽  
Periodic Evaluation ◽  
The Tropics ◽  
Egg Reduction Rate

Background. Soil-transmitted helminths (STHs) and Schistosoma mansoni are the main causes of morbidity among schoolchildren in the tropics. A school-based deworming program was launched to control and eliminate the infection in endemic countries including Ethiopia. Although periodic deworming is conducted in endemic areas, the prevalence of the infection is high in the country. In addition, periodic evaluation of the efficacy of the anthelminthic drug is limited. Objective. This study is aimed at checking the efficacy of mebendazole and praziquantel with the respective STHs and Schistosoma mansoni parasites. Methods. A longitudinal study was conducted from February to March 2018 among 422 schoolchildren. Stool samples were collected at baseline and at 2 and 4 weeks posttreatment and were processed using the Kato-Katz technique. Schoolchildren positive for STHs were treated with mebendazole and those positive for Schistosoma mansoni with praziquantel. After two weeks, a second round of stool was collected and examined, and then, single-dose redosing was given to each positive child. Lastly, the third stool sample was collected two weeks after the initiation of the redosing and checked for STHs and S. mansoni parasites. A close follow-up of students who were treated was done. All the data were entered and analyzed using SPSS version 20 for analysis. Descriptive statistics was used to compute the cure rate and egg reduction rate of mebendazole and praziquantel. Results. Among 422 participants, the prevalence of STHs, hookworm, Ascaris lumbricoides, and S. mansoni was 44.7%, 35.1%, 21.1%, and 13.9%, respectively. The cure rate of mebendazole against A. lumbricoides increased from 60% in the single dose to 100% in redosing after two weeks. The cure rate of mebendazole against hookworm also increased from 32.4% in the single dose to 91.0% in the redosing. The cure rate of praziquantel against S. mansoni-infected children was 91.5% in the first round and 100% in the redosing phase. There was a 98.6-100% egg reduction rate in the redosing regimen of both drugs. Conclusion. The cure and egg reduction rates of single-dose mebendazole in the treatment of hookworm and A. lumbricoides are lower at week two than at redosing, while cure and egg reduction rates of single-dose praziquantel are satisfactory to treat S. mansoni. Therefore, single-dose praziquantel to S. mansoni and redosing of single-dose mebendazole to A. lumbricoides and hookworm infections can be used for treatment purposes.

Immunogenicity of Subcutaneous Versus Intramuscular Oka/Merck Varicella Vaccination in Healthy Children

PEDIATRICS ◽  
1991 ◽  
Vol 88 (3) ◽  
pp. 604-607
Author(s):  
Penelope H. Dennehy ◽  
Keith S. Reisinger ◽  
Mark M. Blatter ◽  
Barbara A. Veloudis
Keyword(s):  
Geometric Mean ◽  
Varicella Vaccine ◽  
Varicella Vaccination ◽  
Prior History ◽  
Healthy Children ◽  
Geometric Mean Titer ◽  
Clinical Events ◽  
History Of ◽  
The Mean ◽  
To Receive

To compare the immunogenicity and safety of varicella vaccine by either subcutaneous or intramuscular injection, 166 healthy children aged 12 months to 10 years old who had no prior history of varicella were enrolled from two pediatric practices and randomly assigned to receive 0.5 mL of a single lot of varicella vaccine. Sera from the day of and 6 weeks postvaccination were tested for varicella antibody by gpELISA. Parents recorded clinical events occurring in the 6 weeks following vaccination. In the 132 evaluable children, the mean prevaccination titer was 0.3 gpELISA units for both groups. Sixty-three (97%) of the 65 receiving varicella vaccine by the subcutaneous route seroconverted compared with 67 (100%) of 67 immunized intramuscularly. Postvaccination geometric mean titer in the subcutaneous group was 6.9 ± 7.0 gpELISA units and did not differ significantly from the geometric mean titer of 10.5 ± 4.4 in the intramuscular group. Varicella vaccine was generally well tolerated by either route; 21% of both groups complained of reactions at the injection site and 7% had a varicella-like rash. Although varicella vaccine is recommended to be given subcutaneously, the results of this study indicate that inadvertent intramuscular administration of varicella vaccine is not reason for revaccination.

scholarly journals Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

2005 ◽  
Vol 49 (10) ◽  
pp. 4035-4041 ◽  
Author(s):  
Joseph D'Ignazio ◽  
Marco A. Camere ◽  
Drew E. Lewis ◽  
Daniel Jorgensen ◽  
Jeanne D. Breen
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Clinical Cure ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Treatment Difference ◽  
Treatment Regimens ◽  
Protocol Population ◽  
Cure Rates ◽  
To Receive

ABSTRACT This randomized, double-blind, noninferiority study was designed to demonstrate that a single 2.0-g oral dose of a novel microsphere formulation of azithromycin was at least as effective as 7 days of levofloxacin, 500 mg/day, in the treatment of adult patients with mild to moderate community-acquired pneumonia (Fine classes I, II, and III). In total, 427 subjects were randomly assigned to receive either a single 2.0-g dose of azithromycin microspheres (n = 213) or a 7-day regimen of levofloxacin (n = 214). At baseline, 219 of 423 (51.8%) treated subjects had at least one pathogen identified by culture, PCR, or serology. The primary end point was the clinical response (cure or failure) in the “clinical per protocol” population at test of cure (days 13 to 24). Clinical cure rates were 89.7% (156 of 174) for azithromycin microspheres and 93.7% (177 of 189) for levofloxacin (treatment difference, −4.0%; 95% confidence interval, −9.7%, 1.7%). Bacteriologic success at test of cure in the “bacteriologic per protocol” population was 90.7% (97 of 107) for azithromycin microspheres and 92.3% (120 of 130) for levofloxacin (treatment difference, −1.7%; 95% confidence interval, −8.8%, 5.5%). Both treatment regimens were well tolerated; the incidence of treatment-related adverse events was 19.9% and 12.3% for azithromycin and levofloxacin, respectively. A single 2.0-g dose of azithromycin microspheres was at least as effective as a 7-day course of levofloxacin in the treatment of mild to moderate community-acquired pneumonia in adult outpatients.

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