Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Gutman, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01082705
First received: March 8, 2010
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

Following the rapid development of significant drug resistance to both chloroquine and sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that this drug has been widely used for some time, the investigators propose to conduct an antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if this drug remains efficacious, or if significant resistance has emerged, in which case a new antimalarial strategy will need to be contemplated. The investigators hypothesize that the efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination therapies will be equally efficacious.

Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.


Condition Intervention Phase
P. Falciparum Malaria
Drug: artemether-lumefantrine
Drug: Dihydroartemisinin-piperaquine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact Tanzania in Vivo Efficacy 2010: Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children Aged 6-59 Months

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematologic response to treatment measured as mean change in hemoglobin concentration from Day 0 to Day 42 [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Artemether-lumefantrine
Artemether-lumefantrine (Coartem; Novartis) administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of: 1 tablet for patients weighing 5-14 kg, 2 tablets for patients weighing 15-24 kg, 3 tablets for patients weighing 25-34 kg, 4 tablets for patients weighing 35 kg or more
Drug: artemether-lumefantrine
administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of: 1 tablet for patients weighing 5-14 kg, 2 tablets for patients weighing 15-24 kg, 3 tablets for patients weighing 25-34 kg, 4 tablets for patients weighing 35 kg or more
Other Name: Coartem Novartis
Experimental: Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine administered once daily for 3 days as tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine at a total dosage of 6.4 mg/kg of dihydroartemisinin and 51.2 mg/kg of piperaquine divided equally between the three days
Drug: Dihydroartemisinin-piperaquine
once daily for 3 days as tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine at a total dosage of 6.4 mg/kg of dihydroartemisinin and 51.2 mg/kg of piperaquine divided equally between the three days

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 6-59 months
  2. Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours
  3. Weight ≥ 5.0 kg
  4. Slide-confirmed infection with P. falciparum, with parasitemia 2,000-200,000 asexual forms per μl
  5. Live within the boundaries of the officially recognized catchment area of Miono Health Center.
  6. Caregiver agrees to all blood draws and return visits.

Exclusion Criteria:

  1. General danger signs or symptoms of severe malaria
  2. Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (National Center for Health Statistics [NCHS]/World Health Organization [WHO] normalized reference values)
  3. Slide confirmed infection with any other Plasmodium spp. besides falciparum or mixed plasmodium infection
  4. Severe anemia, defined as Hb < 5 g/dl
  5. Known hypersensitivity to any of the drugs being tested
  6. Presence of febrile conditions caused by diseases other than malaria
  7. Serious or chronic medical condition (heart failure, sickle cell disease).
  8. Plan to travel or leave the area within the next 3 months.
  9. Have been treated for malaria in the 2 weeks prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082705

Locations
Tanzania
Miono Health Center
Bagamoyo, Tanzania
Sponsors and Collaborators
Investigators
Study Director: Julie R Gutman, MD MSc Centers for Disease Control and Prevention
Principal Investigator: S. Patrick Kachur, MD MPH Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Julie Gutman, Medical Epidemiologist, Malaria Branch, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01082705     History of Changes
Other Study ID Numbers: IMPACT TZ IV2010
Study First Received: March 8, 2010
Last Updated: January 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
malaria
treatment
artemisinin combination therapy
Tanzania
P. falciparum malaria in children age 6-59 months

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Piperaquine
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Artemether
Dihydroartemisinin
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on September 22, 2014