CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Methylene Blue +1 moredrug
Likely dose
Not stated in 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/NCT02851108
NCT02851108Phase 2Completed

Safety of Artesunate-amodiaquine Combined With Methylene Blue or Primaquine for Falciparum Malaria Treatment in African Children: A Randomised Controlled Trial

Heidelberg University·interventional·Posted Aug 1, 2016·Updated Mar 25, 2020

In Brief

A Phase 2 clinical trial evaluating Methylene Blue and Primaquine for Malaria, Falciparum. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum malaria treatment in African children: A randomised controlled trial Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. As resistance against artemisinin compounds has recently started to emerge in South-East Asia, there is a clear need to develop alternative malaria drug combinations. Adding another anti-malarial with a short half-life such as methylene blue to standard ACT (artemisinin-based combination therapy) could be a strategy to prevent artemisinin resistance development. Moreover, adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum parasites including drug-resistant parasites. Objectives: The primary objective of this trial is to investigate the safety of artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young children with uncomplicated falciparum malaria in Burkina Faso.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBurkina Faso

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 1, 2016
Enrollment StartOct 1, 2016
Primary CompletionDec 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.9 years ago

Interventions

Methylene Bluedrug

50 patients will receive methylene blue

Primaquinedrug

50 patients will receive primaquine