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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidectin 8 mg | Experimental | A single tablet of 8 mg of moxidectin |
|
| Moxidectin 8 mg + Albendazole | Experimental | A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg) |
|
| Moxidectin 16 mg | Experimental | Two tablets of 8 mg of moxidectin ( = 16 mg) |
|
| Moxidectin 16 mg + Albendazole | Experimental | Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg) |
|
| Moxidectin 24 mg | Experimental | Three tablets of 8 mg of moxidectin ( = 24 mg) |
|
| Moxidectin 24 mg + Albendazole | Experimental | Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin 8mg | Drug | Participants will receive the tablet with clean water and a package of biscuits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri, P.O. Box 122 | Chake Chake | Pemba | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31044235 | Derived | Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020 Mar 3;70(6):1193-1201. doi: 10.1093/cid/ciz326. |
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Participants will receive placebos. Outcome assessors and caregivers will not have access to the list of children allocated to each treatment arm.
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| Placebo | Placebo Comparator | A single tablet of placebo |
|
| Moxidectin 8 mg + albendazole 400 mg | Drug | Participants will receive the tablets with clean water and a package of biscuits. |
|
| Moxidectin 16 mg | Drug | Participants will receive the tablets with clean water and a package of biscuits. |
|
| Moxidectin 16 mg + albendazole 400 mg | Drug | Participants will receive the tablets with clean water and a package of biscuits. |
|
| Moxidectin 24 mg | Drug | Participants will receive the tablets with clean water and a package of biscuits. |
|
| Moxidectin 24 mg + albendazole 400 mg | Drug | Participants will receive the tablets with clean water and a package of biscuits. |
|
| Placebo | Other | Participants will receive the tablet with clean water and a package of biscuits. |
|
| Cure rate of the different drug regimens against Ascaris lumbricoides | Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment. | 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. | 6 weeks |
| Cure rate against hookworm | Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment. | 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. | 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. | 6 weeks |
| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C027837 | moxidectin |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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