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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
286
Participants will receive the tablet with clean water and a package of biscuits.
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.
Public Health Laboratory Ivo de Carneri, P.O. Box 122
Chake Chake, Pemba, Tanzania
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.
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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.
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.
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