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
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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:
- Age 6-59 months
- Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours
- Weight ≥ 5.0 kg
- Slide-confirmed infection with P. falciparum, with parasitemia 2,000-200,000 asexual forms per μl
- Live within the boundaries of the officially recognized catchment area of Miono Health Center.
- Caregiver agrees to all blood draws and return visits.
Exclusion Criteria:
- General danger signs or symptoms of severe malaria
- 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)
- Slide confirmed infection with any other Plasmodium spp. besides falciparum or mixed plasmodium infection
- Severe anemia, defined as Hb < 5 g/dl
- Known hypersensitivity to any of the drugs being tested
- Presence of febrile conditions caused by diseases other than malaria
- Serious or chronic medical condition (heart failure, sickle cell disease).
- Plan to travel or leave the area within the next 3 months.
- Have been treated for malaria in the 2 weeks prior to enrollment.
Contacts and Locations
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 Artemether Artemisinins Dihydroquinghaosu Piperaquine Lumefantrine Artemether-lumefantrine combination Artemisinine |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics |
ClinicalTrials.gov processed this record on May 21, 2013