Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria
Summary
This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in RDCongo, on malaria incidence and its potential selection of resistant strains. Patients will be followed-up for efficacy and safety during 42 days after treatment with the first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or an other ACT or oral Quinine + clyndamicin. The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14 days is as efficacious as any other rescue treatment, without the risk of selecting drug resistant strains.
Timeline
- Start
- 2012-05
- Primary completion
- 2014-06
- Completion
- 2014-06
Publications
- Mavoko HM, Nabasumba C, da Luz RI, Tinto H, D'Alessandro U, Kambugu A, Baraka V, Rosanas-Urgell A, Lutumba P, Van Geertruyden JP. Efficacy and safety of re-treatment with the same artemisinin-based combination treatment (ACT) compared with an alternative ACT and quinine plus clindamycin after failure of first-line recommended ACT (QUINACT): a bicentre, open-label, phase 3, randomised controlled trial. Lancet Glob Health. 2017 Jan;5(1):e60-e68. doi: 10.1016/S2214-109X(16)30236-4. Epub 2016 Nov 11.
- Muhindo Mavoko H, Kalabuanga M, Delgado-Ratto C, Maketa V, Mukele R, Fungula B, Inocencio da Luz R, Rosanas-Urgell A, Lutumba P, Van Geertruyden JP. Uncomplicated Clinical Malaria Features, the Efficacy of Artesunate-Amodiaquine and Their Relation with Multiplicity of Infection in the Democratic Republic of Congo. PLoS One. 2016 Jun 9;11(6):e0157074. doi: 10.1371/journal.pone.0157074. eCollection 2016.
- Muhindo Mavoko H, Nabasumba C, Tinto H, D'Alessandro U, Grobusch MP, Lutumba P, Van Geertruyden JP. Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial. Trials. 2013 Sep 23;14:307. doi: 10.1186/1745-6215-14-307.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artemether | Small molecule | 20 mg | Oral |
| Subject | Artesunate | Small molecule | 25 mg | Oral |
| Comparator | Clindamycin | Unknown | 10 mg/kg | Oral |
| Comparator | Quinine | Small molecule | 125 mg | Oral |
| Subject | amodiaquine | Other / unclassified | 67.5 mg | Oral |
| Subject | lumefantrine | Small molecule | 120 mg | Oral |