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

Primary Purpose

P. Falciparum Malaria

Status

Completed

Phase

Phase 3

Locations

Tanzania

Study Type

Interventional

Intervention

artemether-lumefantrine

Dihydroartemisinin-piperaquine

About this trial

This is an interventional treatment trial for P. Falciparum Malaria focused on measuring malaria, treatment, artemisinin combination therapy, Tanzania, P. falciparum malaria in children age 6-59 months

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Miono Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Artemether-lumefantrine

Dihydroartemisinin-piperaquine

Arm Description

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

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

Outcomes

Primary Outcome Measures

42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia

Secondary Outcome Measures

Hematologic response to treatment measured as mean change in hemoglobin concentration from Day 0 to Day 42

Full Information

NCT ID

NCT01082705

First Posted

March 8, 2010

Last Updated

January 27, 2012

Sponsor

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01082705

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

P. Falciparum Malaria

Keywords

malaria, treatment, artemisinin combination therapy, Tanzania, P. falciparum malaria in children age 6-59 months

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artemether-lumefantrine

Arm Type

Active Comparator

Arm Description

Arm Title

Dihydroartemisinin-piperaquine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

artemether-lumefantrine

Other Intervention Name(s)

Coartem Novartis

Intervention Description

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

Intervention Name(s)

Dihydroartemisinin-piperaquine

Intervention Description

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

Primary Outcome Measure Information:

Title

42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia

Time Frame

42 days

Secondary Outcome Measure Information:

Title

Hematologic response to treatment measured as mean change in hemoglobin concentration from Day 0 to Day 42

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie R Gutman, MD MSc

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

S. Patrick Kachur, MD MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miono Health Center

City

Bagamoyo

Country

Tanzania

12. IPD Sharing Statement

Learn more about this trial

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

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