Trial · NCT05879224
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment | During treatment (up to 8 weeks) ] | SAEs are collected during clinical review using a study-specific questionnaire |
| Primary | Proportion of patients experiencing at least one Adverse Event of Special Interest(AESI) during treatment | During treatment (up to 8 weeks) | AESIs (haemolysis, methaemoglobinaemia and gastrointestinal discomfort) are collected during clinical review using a study-specific questionnaire |
| Primary | Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package | 3 days | Measured by completion of G6PD testing and the correct prescription of primaquine based on G6PD activity, completion of patients counselling and community based follow up on Day 3 |
| Secondary | The proportion of patients with any AESI during treatment | During treatment (up to 8 weeks) | AESIs are collected during clinical review using a study-specific questionnaire |
| Secondary | The proportion of patients with a gastrointestinal (GI) AESI during treatment | During treatment (up to 8 weeks) | AESIs are collected during clinical review using a study-specific questionnaire |
| Secondary | The proportion of patients with an AESI related to haemolysis during treatment | During treatment (up to 8 weeks) ] | AESIs are collected during clinical review using a study-specific questionnaire |
| Secondary | The proportion of patients an AESI related to methaemoglobinaemia | During treatment (up to 8 weeks) | AESIs are collected during clinical review using a study-specific questionnaire |
| Secondary | Proportion of patients permanently stopping PQ before end of treatment | During treatment (up to 8 weeks) | Discontinuation of PQ will be assessed using a study-specific questionnaire |
| Secondary | The proportion of patients receiving correct treatment based on G6PD activity | 1 day | This will be assessed by linking patients G6PD activity results measured during study enrolment with primaquine dose prescribed on the same day |
| Secondary | Proportion of patients who were reviewed on Day 3 and Day 7 | 1 week | This will be assessed by linking patients enrolment data with Day 3 and Day 7clinical review data |
| Secondary | Perception of and experience with new radical cure tools among health care providers and community members | 6 months | This will be assessed using stakeholder interviews |
| Secondary | Proportion of health care practitioners who comply with the revised radical cure treatment algorithm | 1 day | The outcome will be assessed from patients' enrolment data |
| Secondary | Proportion of patients receiving a SD Biosensor G6PD test | 1 day | The outcome will be assessed from patients' enrolment data |
| Secondary | Proportion of eligible P. vivax malaria patients receiving the correct dose of primaquine based on the result of the G6PD test | 1 day | The outcome will be assessed from patients' enrolment data |
| Secondary | Proportion of P. vivax malaria patients who are ineligible for daily primaquine and are incorrectly given primaquine (including infants, pregnant females and G6PD deficient patients | 1 day | The outcome will be assessed from patients' enrolment data |
| Secondary | Proportion of P. vivax malaria patients that are reviewed on Day 3 | 3 days | This will be assessed by linking patients' enrolment data with clinical review data |
| Secondary | Proportion of P. vivax malaria patients that adhere to their prescribed primaquine regimen | 3 days | This will be assessed by linking patients' enrolment data with clinical review data |
| Secondary | Factors influencing acceptability and feasibility of the new radical cure tools among health care providers are identified | 3 days | This will be assessed using stakeholder interviews, observations and focus groups |
| Secondary | Barriers and enablers of uptake and implementation at the sub-national levels are identified | 18 months | This will be assessed using stakeholder interviews and focus groups |
| Secondary | Factors influencing compliance with G6PD testing and perceptions of new drug regimens and serious adverse events among health care providers are identified | 18 months | This will be assessed using stakeholder interviews and focus groups |
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.
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GET https://conductscience.org/api/trials/v1/NCT05879224/registered