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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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.
Timepoint [1] 0 0
At 14 days post-intervention.
Secondary outcome [1] 0 0
Distribution of hookworms species.
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
Sex
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
250
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01379326