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

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ClinicalTrials.gov Identifier: NCT00868465
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : June 7, 2010
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Study Description
Brief 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.

Condition or disease Intervention/treatment
Uncomplicated Malaria Drug: Artemether-Lumefantrine Drug: Dihydroartemisinin-piperaquine

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Artemether-lumefantrine; currently the first line treatment in Tanzania
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
Other Name: Coartem; Riamet
Experimental: 2
Dihydroartemisinin-piperaquine, alternative ACT
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
Other Name: Artekin

Outcome Measures

Primary Outcome Measures :
  1. 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 Frame: during 42 day follow-up ]

Secondary Outcome Measures :
  1. To determine (sub-microscopic) gametocyte carriage after treatment with AL and DP [ Time Frame: during 42 day follow-up ]
  2. To determine malaria transmission to mosquitoes after treatment with AL or DP [ Time Frame: day 7 after initiation treatment ]
  3. To determine molecular markers that are predictive of reduced susceptibility of parasite strains for AL and DP [ Time Frame: day 7 after initiation treatment ]
  4. To determine molecular markers that are related to gametocytaemia or malaria transmission after treatment with AL and DP [ Time Frame: during 42 day follow-up ]
  5. To determine the relation between treatment success and the presence of anti-malaria antibodies [ Time Frame: during 42 day follow-up ]
  6. To explore the role of cellular oxidative stress in treatment with AL and DP [ Time Frame: during 42 day follow-up ]
  7. To determine the relation between transmission to mosquitoes and the presence of anti-malaria antibodies [ Time Frame: day 7 after initiation treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868465

International Centre for Insect Physiology and Ecology - St. Judes Clinic
Mbita, Suba District, Kenya
Kilimanjaro Christian Medical Centre, Magugu Field Site
Moshi, Kilimanjaro Region, Tanzania
Sponsors and Collaborators
Radboud University
Kilimanjaro Christian Medical Centre, Tanzania
European Union
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teun Bousema, Kilimanjaro Christian Medical Centre
ClinicalTrials.gov Identifier: NCT00868465     History of Changes
Other Study ID Numbers: TRANSACT09
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: April 2009

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents