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

P. Falciparum Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082705
• Other study ID #: IMPACT TZ IV2010
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2010
• Last updated: January 27, 2012
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• P. Falciparum Malaria

Intervention

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
• 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

Locations

Country	Name	City	State
Tanzania	Miono Health Center	Bagamoyo

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia		42 days	No
Secondary	Hematologic response to treatment measured as mean change in hemoglobin concentration from Day 0 to Day 42		42 days	No