CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Primaquine +2 moredrug
Likely dose
Primaquine 26.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04666350
NCT04666350N/ACompleted
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Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays in Adults With Varying Plasmodium Falciparum Gametocyte Densities

PATH·observational·Posted Dec 14, 2020·Updated Apr 29, 2024

In Brief

An observational study evaluating Direct Skin Feeding Assay (DSFA), Primaquine, and 1 other intervention for Malaria. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesKenya
CollaboratorsWalter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartMar 9, 2021
Primary CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.5 years ago

Interventions

Direct Skin Feeding Assay (DSFA)other

In the direct feeding assay a cup with 60 unfed, sterile insectary-reared Anopheles gambiae mosquitoes will be allowed to feed on a participant's calf or arm for 15 minutes.

Primaquinedrug

Participants will receive one dose of primaquine 26.3 mg tablet on Day 2 after completion of the direct feeding assay.

Artemether/Lumefantrinedrug

Participants will receive artemether (80 mg) and lumefantrine (480 mg) combination tablets twice a day for 3 days, starting after completion of the direct feeding assay on Day 2.