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

NCT00868465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2010-06-07

No results posted yet for this study

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.

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

Artemether-Lumefantrine

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

DRUG

Dihydroartemisinin-piperaquine

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

Sponsors & Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER

  • European Union

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Kenya
  • Tanzania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868465 on ClinicalTrials.gov