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Completed

NCT Number: NCT01082705

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

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.

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Key information

Conditions

P. Falciparum Malaria Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Miono Health Center

Bagamoyo, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artemether-lumefantrine

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

Other names: Coartem Novartis

Dihydroartemisinin-Piperaquine

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

Primary outcomes

  1. 42-day polymerase chain reaction (PCR)-adjusted parasitological cure of P. falciparum parasitemia

    Time frame: 42 days

Secondary outcomes

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

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2010
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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