A Phase 2 interventional study of Moxidectin 8mg and Moxidectin 8 mg + albendazole 400 mg in Trichuris Trichiura; Infection, sponsored by Swiss Tropical & Public Health Institute. Completed at 1 site in Tanzania. Open to participants aged 16 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Swiss Tropical & Public Health Institute · Phase 2, Interventional, and Treatment
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 286 is close to the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single tablet of 8 mg of moxidectin
Drug: Moxidectin 8mg
A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 8 mg + albendazole 400 mg
Two tablets of 8 mg of moxidectin ( = 16 mg)
Drug: Moxidectin 16 mg
Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 16 mg + albendazole 400 mg
Three tablets of 8 mg of moxidectin ( = 24 mg)
Drug: Moxidectin 24 mg
Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 24 mg + albendazole 400 mg
A single tablet of placebo
Other: Placebo
Participants will receive the tablet with clean water and a package of biscuits.
Drug page: Moxidectin
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Drug page: Moxidectin
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Drug page: Moxidectin
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablet with clean water and a package of biscuits.
Cure rate against Trichuris trichiura
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
Time frame: 6 weeks
Egg Reduction Rate of the different drug regimens against Trichuris trichiura
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 6 weeks
Cure rate of the different drug regimens against Ascaris lumbricoides
Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.
Time frame: 6 weeks
Egg Reduction Rate of Ascaris lumbricoides
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 6 weeks
Cure rate against hookworm
Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.
Time frame: 6 weeks
Egg Reduction Rate of hookworm
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 6 weeks
Number of adverse events at 5 time points
Patients will be kept for observation for at least 3 hours following treatment for any acute adverse events. During the reporting period, any unfavorable changes in the subject's condition will be recorded as adverse events, whether reported by the subject or observed by the Investigator. In case of any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition, patients will be also interviewed by a nurse and/or a physician about the occurrence of adverse events 24, 48 and 72 hours post-treatment using a questionnaire. Finally, upon collection of the first follow-up stool sample participants will be re-questioned.
Time frame: 6 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Moxidectin
Swiss Tropical & Public Health Institute