Trial · NCT06184399
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate (CR) Against T. Trichiura | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 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 | Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 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 Rate (CR) Against A. Lumbricoides | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 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 | Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 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 Rate (CR) Against Hookworm | 14-21 days post-treatment | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. |
| Secondary | Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 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 | Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 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 | Number of Participants Reporting Adverse Events (AEs) | 3 hours, 24 hours and 14-21 days post-treatment | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. |
| Other | Blood Concentration of Ivermectin | 0 to 24 hours post-treatment | For characterization of population pharmacokinetics (PK), ivermectin concentration will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. |
| Other | Acceptability of ODT Assessed by Visual Analogue Scale (0-100 mm) | 15 min post-treatment | To determine the acceptability of ivermectin ODTs compared to standard tablets, the palatability of each formulation will be rated by children aged 4-5 years using a visual analogue scale with continuous scores from 0 mm (worst taste) to 100 mm (best taste). |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06184399/registered