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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
History of Changes

March 8, 2010
January 27, 2012
April 2010
June 2011   (final data collection date for primary outcome measure)
42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia [ Time Frame: 42 days ] [ Designated as safety issue: No ]
42-day PCR-adjusted parasitological cure of P. falciparum parasitemia [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01082705 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
P. Falciparum Malaria
  • 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
  • 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
  • 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
    Intervention: Drug: artemether-lumefantrine
  • 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
    Intervention: Drug: Dihydroartemisinin-piperaquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01082705
IMPACT TZ IV2010
No
Julie Gutman, Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
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
Centers for Disease Control and Prevention
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP