Evaluating the efficacy of different tribendimidine combinations against intestinal worms (soil-transmitted helminths)

• Register: ISRCTN
• Last refreshed on: 11 September 2023
• Main ID: ISRCTN14373201
• Date of registration: 19/07/2016
• Prospective Registration: Yes
• Primary sponsor: Swiss Tropical and Public Health Institute
• Public title: Evaluating the efficacy of different tribendimidine combinations against intestinal worms (soil-transmitted helminths)
• Scientific title: Efficacy and safety of tribendimidine plus oxantel, tribendimidine plus ivermectin, albendazole plus oxantel pamoate and tribendimidine alone against hookworm and concomitant soil-transmitted helminth infections: a randomised controlled multi-country trial
• Date of first enrolment: 25/07/2016
• Target sample size: 640
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14373201
• Study type: Interventional
• Study design: Single-blinded randomized interventional study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Cote d'Ivoire, Tanzania

Contacts

• Name: Jennifer Keiser

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written informed consent signed by parents and/or legal guardian; and assent by children
2. Able and willing to be examined by a study physician at the beginning of the study
3. Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up)
4. Positive for hookworm eggs in the stool
5. Absence of major systemic illnesses (e.g. diabetes, anemia) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No known allergy to study medications (e.g. albendazole, mebendazole)
9. Aged 15-18 years
Exclusion criteria: 1. No written informed consent by parents and/or legal guardian and assent for children
2. Presence of major systemic illnesses (e.g. diabetes, anemia) as assessed by a medical doctor, upon initial clinical assessment
3. History of acute or severe chronic disease
4. Recent use of anthelminthic drug (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for hookworm eggs in the stool

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hookworm infection
Infections and Infestations
Hookworm infection

Intervention(s)

Study participants eligible for treatment will be randomly assigned to one of the four treatment arms using a computer-generated stratified block randomization code. The random allocation sequence with varying random blocks of four or eight will be provided by a statistician.

Group 1: One single dose of tribendimidine (400mg) plus oxantel pamoate (25mg/kg)
Group 2: One single dose of tribendimidine (400mg) plus ivermectin (200µg/kg)
Group 3: One single dose of tribendimidine (400mg) plus placebo
Group 4: One single dose of albendazole (400mg) plus oxantel pamoate (25mg/kg)

At follow-up (after 14-21 days) participants will be asked to provide a second time two stool samples on two consecutive days.

Primary Outcome(s)

Egg-reduction rates against hookworm are measured calculating the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smears).

Secondary Outcome(s)

1. Cure rate (CR) against hookworm is the percentage of children egg negative calculated at follow-up (14-21 days post treatment) based on a quadruplicated Kato-Katz thick smear
2. Cure rate (CR) and egg-reduction rate (ERR) against A. lumbricoides and T. trichiura are egg free children at follow-up (14-21 days post treatment based on a quadruplicated Kato-Katz thick smear) or the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smear)
3. Pharmacokinetic parameters are determined based on concentration of the different drugs measured
4. Safety is measured based on number of children reporting adverse events at the time points 3 and 24 hours post treatment using a standardized questionnaire

Secondary ID(s)

N/A

Source(s) of Monetary Support

Swiss National Science Foundation

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Ethikkommission Nordwest-und Zentralschweiz EKNZ, 25/06/2015, ref: EKNZ UBE 15/35 (Switzerland) 2. Zanzibar Medical Research and Ethics Committee ZAMREC, 11/07/2016, ref: ZAMREC /0001/July/016 (Tanzania) 3. Comité National d'Ethique pour la Recherche CNER, 09/09/2016, ref : 083/MSHP/CNER-kp

Results

• Results available: Yes
• Date Completed: 01/05/2017