Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital

Randomised controlled trial of two sequential artemisinin-based combination therapy regimens to treat uncomplicated falciparum malaria in African children: a protocol to investigate safety, efficacy and adherence

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Changes in depression in a cohort of Danish HIV-positive individuals: time for routine screening

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Making a difference for quality of care and patient safety: Research with and about simulation

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Temporal Pattern of Mutations in the Knockdown Resistance (kdr) Gene of Aedes aegypti Mosquitoes Sampled from Southern Taiwan

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Schistosomiasis

    Research output: Chapter in Book/Report/Conference proceedingBook chapterCommunication

View graph of relations

BACKGROUND: Management of uncomplicatedPlasmodium falciparummalaria relies on artemisinin-based combination therapies (ACTs). These highly effective regimens have contributed to reductions in malaria morbidity and mortality. However, artemisinin resistance in Asia and changing parasite susceptibility to ACT in Africa have now been well documented. Strategies that retain current ACT as efficacious treatments are urgently needed.

METHODS: We present an open-label, randomised three-arm clinical trial protocol in three African settings representative of varying malaria epidemiology to investigate whether prolonged ACT-based regimens using currently available formulations can eliminate potentially resistant parasites. The protocol investigates whether a sequential course of two licensed ACT in 1080 children aged 6-120 months exhibits superior efficacy against acuteP. falciparummalaria and non-inferior safety compared with standard single-course ACT given to 540 children. The primary endpoint is PCR-corrected clinical and parasitological response at day 42 or day 63 of follow-up. Persistence of PCR-detectable parasitaemia at day 3 is analysed as a key covariate. Secondary endpoints include gametocytaemia, occurrence of treatment-related adverse events in the double-ACT versus single-ACT arms, carriage of molecular markers of drug resistance, drug kinetics and patient adherence to treatment.

DISCUSSION: This protocol addresses efficacy and safety of sequential ACT regimens inP. falciparummalaria in Africa. The approach is designed to extend the useful life of this class of antimalarials with maximal impact and minimal delay, by deploying licensed medicines that could be swiftly implemented as sequential double ACT by National Malaria Control Programmes, before emerging drug resistance in Africa becomes a major threat to public health.

Original languageEnglish
JournalGlobal Health
Issue number3
Pages (from-to)e000371
Publication statusPublished - 30 Aug 2017

    Research areas

  • Journal Article

ID: 52821250