Efficacy and safety of of tribendimidine against hookworm infections in children: a randomized controlled trial
| ISRCTN | ISRCTN81391471 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81391471 |
| Secondary identifying numbers | v.1.02 |
- Submission date
- 19/05/2017
- Registration date
- 19/05/2017
- Last edited
- 04/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Parasitic worms are organisms that live in the intestine and feed off their living hosts. There are many types of parasitic worms, including the hookworm. They are among the most common type of infections worldwide, especially in poor and deprived communities. They are spread by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor. An infection can cause malnutrition, physical and mental retardation, and reduced work performance in older age. Few drugs are available which are widely used in the treatment of parasitic worm infections and drug resistance is a growing problem. Tribendimidine is a broad-spectrum anti-parasitic worm drug which has been developed in China. The aim of this study is to find out the best dose of this drug to give to children with hookworm infections.
Who can participate?
Children aged between six and twelve years who have hookworm eggs in their stool.
What does the study involve?
Participants are randomly allocated to one of five groups. Those in the first group receive a single dose of 100 mg tribendimidine. Those in the second group receive a single dose of 200 mg tribendimidine. Those in the third group receive a split 200 mg tablet of tribendimidine. Those in the next group receive a single dose of a placebo (dummy drug). 21 days after receiving the treatment, participants provide a stool sample which is then tested for signs of parasitic worm eggs. Participants are also interviewed before treatment, 3 and 24 hours after treatment about whether they have experienced any side effects.
What are the possible benefits and risks of participating?
All participants benefit from receiving a clinical examination and hookworm infection treatment. STHs. All participating children remaining positive for hookworm at the end of the study will be treated with another medication (according to WHO recommendations). There are no notable risks involved with participating.
Where is the study run from?
Rubino Health Center (Cote d’Ivoire)
When is the study starting and how long is it expected to run for?
January 2017 to December 2017
Who is funding the study?
European Research Council (Belgium)
Who is the main contact?
Professor Jennifer Keiser
jennifer.keiser@unibas.ch
Contact information
Scientific
Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4051
Switzerland
| Phone | +41 612 848 218 |
|---|---|
| jennifer.keiser@unibas.ch |
Study information
| Study design | Single blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of ascending dosages of tribendimidine against hookworm and concomitant soil-transmitted helminth infections in children: a randomized controlled trial |
| Study objectives | The aim of this study is to compare the efficacy and safety of three oral tribendimidine dosages (100 mg, 200 mg and 400 mg) versus placebo in school-aged children infected with hookworm and to measure tribendimidine disposition using dried blood spot technology. |
| Ethics approval(s) | 1. Ethics committee of Northwestern and Central Switzerland (EKNZ) 03/04/2017, ref: 2017-00139 2. Ministere de la Sante et de hygiene publique, comite nationa d'ethique de la recherche, 17/04/2017, ref: 053/IMSHP/CNER-kp |
| Health condition(s) or problem(s) studied | Hookworm infection |
| Intervention | Current interventions as of 25/07/2017: Single, oral tribendimidine 100, 200 and 400 mg and placebo. Patients will be randomized using block randomization to one of four groups. Intervention group 1: Participants receive a single dose of oral tribendimidine 100 mg Intervention group 2: Participants receive a single dose of oral tribendimidine 200 mg Intervention group 4: Participants receive a single dose of oral tribendimidine 400 mg Control group: Participants receive a single dose of a placebo Follow up will be conducted for all treatment arms 21 days after treatment. Previous interventions: Single, oral tribendimidine 100, 200 and 400 mg and placebo. Patients will be randomized using block randomization to one of four groups. Intervention group 1: Participants receive a single dose of oral tribendimidine 100 mg Intervention group 2: Participants receive a single dose of oral tribendimidine 200 mg Intervention group 3: Participants receive a single dose of oral tribendimidine 200 mg split tablet Intervention group 4: Participants receive a single dose of oral tribendimidine 400 mg Control group: Participants receive a single dose of a placebo Follow up will be conducted for all treatment arms 21 days after treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Tribendimidine |
| Primary outcome measure | Cure rate (conversion from being egg positive pre-treatment to egg negative post-treatment) against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment. |
| Secondary outcome measures | 1. Egg reduction rate against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment 2. Cure and egg reduction rate against concomitant soil-transmitted helminths will be assessed using the quadruple Kato-Katz method at 21 days post-treatment 3. Safety will be assessed with evaluation of adverse events of the treated subjects based on interviews at 3 and 24 hours after treatment 4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 3, 4, 5, 6, 7, 7.5, 8.5 and 24 hours post-dosing |
| Overall study start date | 01/01/2017 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Written informed consent signed by parents and/or legal representative; and oral assent by child 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, severe anemia, clinical malaria 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 tribendimidine 9. Age range is 6-12 years old |
| Key exclusion criteria | 1. No written informed consent by parents and/or legal representative 2. Presence of major systemic illnesses, e.g. diabetes, severe anemia, clinical malaria 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 |
| Date of first enrolment | 25/05/2017 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- Côte d'Ivoire
Study participating centre
0000
Côte d'Ivoire
Sponsor information
Research organisation
Socinstrasse 57
Basel
4051
Switzerland
"ROR" |
https://ror.org/03adhka07 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- ERC
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned scientific publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from jennifer.keiser@unibas.ch |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/08/2018 | Yes | No | |
| Basic results | 04/01/2019 | 04/01/2019 | No | No | |
| Results article | results | 16/08/2019 | Yes | No |
Additional files
- ISRCTN81391471_BasicResults_04Jan19.pdf
- Uploaded 04/01/2019
Editorial Notes
04/01/2019: Publication references added. The basic results of this trial have been uploaded as an additional file.
25/07/2017: Target number of participants has been updated from 200 to 160. Interventions have been updated.
