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

NCT ID: NCT01082705

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

Brief Summary

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.

Conditions

P. Falciparum Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

artemether-lumefantrine

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Dihydroartemisinin-piperaquine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Coartem Novartis

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Julie Gutman

Medical Epidemiologist, Malaria Branch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie R Gutman, MD MSc

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

S. Patrick Kachur, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

Miono Health Center

Bagamoyo, , Tanzania

Countries

Tanzania

Other Identifiers

IMPACT TZ IV2010

Identifier Type: -

Identifier Source: org_study_id