Efficacy and safety of moxidectin alone and in combination against Trichuris trichiura infection: a randomised controlled trial

Efficacy and safety of moxidectin plus albendazole, moxidectin plus tribendimidine, and moxidectin alone versus albendazole plus oxantel pamoate against Trichuris trichiura and concomitant soil-transmitted helminth infections: a randomised controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20398469

Enrollment

640

Registered

2017-02-28

Start date

2017-03-15

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection with Trichuris trichiura and other soil-transmitted helminths Infections and Infestations

Interventions

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 wit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent signed by participants (if 18 years old), parents and/or legal guardian; and oral assent by participants 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 one and three weeks after treatment (follow-up) 4. Positive for T. trichiura eggs in the stool 5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or organ failure) as assessed by a medical doctor, upon initial clinical assessment 6. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease. 7. No recent anthelminthic treatments (within past 2 months) 8. No known allergy to study medications 9. Age 12-18 years

Exclusion criteria

Exclusion criteria: 1. No written informed consent by participants, parents and/or legal guardian 2. Presence of any abnormal medical condition judged by the study physician 3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease 4. Recent use of anthelminthic drugs (within past 2 months) 5. Attending other clinical trials during the study 6. Negative diagnostic result for T. trichiura eggs in stool samples 7. Age below 12 years

Design outcomes

Primary

Measure	Time frame
The egg reduction rates (ERRs) of moxidectin and the combinations moxidectin/tribendimidine and moxidectin/albendazole against T. trichiura will be assessed using the quadruple Kato-Katz method 21 days after treatment.	—

Secondary

Measure	Time frame
1. Efficacy in terms of CR against T. trichiura and CR and ERR against co-infections using the quadruple Kato-Katz method 21 days after treatment 2. Safety will be assessed with evaluation of the treated subjects at 3, 24 and 48 hours after treatment	—

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026