Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2 (ConWorm)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01379326|
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : December 5, 2014
The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted Helminths (STH).
The primary objective is:
(1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and Cure Rate (CR).
The secondary objectives are:
- to assess the occurrence of Necator americanus and Ancylostoma duodenal.
- to assess the occurrence of β-tubulin mutations related to resistance before and after drug administration.
- to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.
|Condition or disease||Intervention/treatment||Phase|
|Ascaris Lumbricoides Ascaris Suum Trichuris Trichiura Trichuris Vulpis Ancylostoma Duodenal Ancylostoma Caninum Ancylostoma Ceylanicum Necator Americanus||Drug: Mebendazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of a Single-dose Mebendazole Against Soil-transmitted Helminths in School Children|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
All children providing stool samples will be treated with mebendazole single table of 500mg under supervision (chewing + water).
- Reduction of fecal egg counts at 14 days post-intervention. [ Time Frame: At 14 days post-intervention. ]Fecal egg counts at intervention and at 14 days follow-up.
- Distribution of hookworms species. [ Time Frame: Samples will be collected at 14 days of follow-up. ]Presence of zoonotic Soil-Transmitted Helminths species, mutations linked with anthelminthic resistance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379326
|Buenos Aires, Argentina|
|Commonwealth Scientific and Industrial Research Organisation|
|Queensland Institute for Medical Research, University of Queensland|
|Herston QLD, Australia|
|Fundação Oswaldo Cruz|
|Belo Horizonte, Brazil|
|Institut Pasteur in Cambodia, Clinical Pathology Unit|
|Phnom Penh, Cambodia|
|University of Yaoundé I|
|Yaoundé I, Cameroon|
|College of Public Health and Medical Sciences, Jimma University|
|Ivo de Carneri, Pemba Island|
|National Institute for Malariology, Parasitology and Entomology|