Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy (TRANSACT)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL and there have been very few clinical trials that compared different ACT regimens. A recent clinical trial shows that the combination of dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment malaria transmission can assist in preventing the development and spread of ACT resistance.

In the current study, the investigators compared AL and DP for the treatment of uncomplicated malaria. The investigators endpoints are

• clinical efficacy

• post-treatment gametocytaemia by molecular techniques

• post-treatment malaria transmission.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborators: European Union; Kilimanjaro Christian Medical Centre, Tanzania
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artenimol; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

• Age 6 months - 10 years

• Residents of research area (5 km around the clinic)

• Willingness to come for complete scheduled follow-up.

• Uncomplicated malaria with P. falciparum mono-infection

• Parasitaemia of 1000-200,000 parasites/ul

• Temperature > 37.5°C and < 39.5°C, or history of fever in previous 24 hours.

• No history of adverse reactions to AL

• Understanding of the procedures of the study by parent or guardian and willing to participate by signing informed consent forms.

Exclusion Criteria:

• General signs of severe malaria

• Haemoglobin concentration < 5g/dl

• Presence of disease other than malaria causing febrile conditions

• Mixed infection with P. malariae or other non-falciparum malaria species

• Unwilling to participate and sign informed consent forms.