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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01379326




Registration number
NCT01379326
Ethics application status
Date submitted
21/06/2011
Date registered
23/06/2011
Date last updated
5/12/2014

Titles & IDs
Public title
Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2
Scientific title
The Efficacy of a Single-dose Mebendazole Against Soil-transmitted Helminths in School Children
Secondary ID [1] 0 0
2011/374
Universal Trial Number (UTN)
Trial acronym
ConWorm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascaris Lumbricoides 0 0
Ascaris Suum 0 0
Trichuris Trichiura 0 0
Trichuris Vulpis 0 0
Ancylostoma Duodenal 0 0
Ancylostoma Caninum 0 0
Ancylostoma Ceylanicum 0 0
Necator Americanus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mebendazole

Experimental: Mebendazole -


Treatment: Drugs: Mebendazole
All children providing stool samples will be treated with mebendazole single table of 500mg under supervision (chewing + water).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction of fecal egg counts at 14 days post-intervention. - Fecal egg counts at intervention and at 14 days follow-up.
Timepoint [1] 0 0
At 14 days post-intervention.
Secondary outcome [1] 0 0
Distribution of hookworms species. - Presence of zoonotic Soil-Transmitted Helminths species, mutations linked with anthelminthic resistance.
Timepoint [1] 0 0
Samples will be collected at 14 days of follow-up.

Eligibility
Key inclusion criteria
Minimum age
4 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who are unable to provide a stool sample at follow-up

- Subjects who are experiencing a severe concurrent medical condition

- Subjects with diarrhea at first sampling

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Commonwealth Scientific and Industrial Research Organisation - Brisbane
Recruitment hospital [2] 0 0
Queensland Institute for Medical Research, University of Queensland - Herston QLD
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Herston QLD
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Brazil
State/province [2] 0 0
Belo Horizonte
Country [3] 0 0
Cambodia
State/province [3] 0 0
Phnom Penh
Country [4] 0 0
Cameroon
State/province [4] 0 0
Yaoundé I
Country [5] 0 0
Ethiopia
State/province [5] 0 0
Jimma
Country [6] 0 0
Tanzania
State/province [6] 0 0
Zanzibar
Country [7] 0 0
Vietnam
State/province [7] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Other
Name
University Ghent
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
World Health Organization
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Institut Pasteur, Cambodia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The University of Queensland
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Oswaldo Cruz Foundation
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Nottingham
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Yaounde 1
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Ivo de Carneri, Pemba Island, Tanzania
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
National Institute of Malariology, Parasitology and Entomology, Vietnam
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Jimma University
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Fundación Huésped
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Queensland Institute of Medical Research
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Commercial sector/Industry
Name [13] 0 0
Institut Pasteur
Address [13] 0 0
Country [13] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Objectives:

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:

1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.

2. to assess the occurrence of ß-tubulin mutations related to resistance before and after
drug administration.

3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.
Trial website
https://clinicaltrials.gov/show/NCT01379326
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications