Trial · NCT04700423
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Egg Reduction Rate Against T. Trichiura | 14-21 day post-treatment | Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels. |
| Secondary | Number of Participants With Adverse Events | 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is 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. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. |
| Secondary | Superiority in Terms of Cure Rates (CRs) | 14-21 day post-treatment | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura. |
| Secondary | Cure Rates Against T. Trichiura | 14-21 day post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Eggs per gram of stool 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. |
| Secondary | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 3 months post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 14-21 days post-treatment | 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. |
| Secondary | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 14-21 days post-treatment | Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 3 months post-treatment | Eggs per gram of stool 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. |
| Secondary | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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