SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00868465

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT00868465 Uncomplicated Malaria
MeSH: Malaria

2 Interventions

Name: Artemether-Lumefantrine

Description: Treatment with artemether-lumefantrine (AL; Coartem; Novartis Pharma), administered as half a tablet (20 mg of artemether and 120 mg of lumefantrine) per 5 kg of body weight in a 6-dose regimen (at enrolment and 8, 20, 32, 44, and 56 h [+/-90 min] after the initiation of treatment). AL is currently the first line treatment in Tanzania

Type: Drug

1

Name: Dihydroartemisinin-piperaquine

Description: Dihydroartemisinin-piperaquine (DP; Artekin; Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets), with a dihydroartemisinin dose of 2.5 mg per kilogram and a piperaquine phosphate dose of 20 mg per kilogram daily for 3 days. DH is registered in Tanzania as Artekin and has been tested extensively in Asia and recently in clinical trials in Uganda and Rwanda

Type: Drug

2


Primary Outcomes

Measure: To determine the clinical efficacy of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) in the treatment of uncomplicated falciparum malaria in children living in north-western Tanzania and in western Kenya.

Time: during 42 day follow-up

Secondary Outcomes

Measure: To determine (sub-microscopic) gametocyte carriage after treatment with AL and DP

Time: during 42 day follow-up

Measure: To determine malaria transmission to mosquitoes after treatment with AL or DP

Time: day 7 after initiation treatment

Measure: To determine molecular markers that are predictive of reduced susceptibility of parasite strains for AL and DP

Time: day 7 after initiation treatment

Measure: To determine molecular markers that are related to gametocytaemia or malaria transmission after treatment with AL and DP

Time: during 42 day follow-up

Measure: To determine the relation between treatment success and the presence of anti-malaria antibodies

Time: during 42 day follow-up

Measure: To explore the role of cellular oxidative stress in treatment with AL and DP

Time: during 42 day follow-up

Measure: To determine the relation between transmission to mosquitoes and the presence of anti-malaria antibodies

Time: day 7 after initiation treatment

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 S769N

This resistance was associated with SNPs at codon S769N of the ATPase6 locus of P. falciparum. --- S769N ---



HPO Nodes