Ethiopia Malaria Therapeutic Efficacy Study

NCT01052584 | Completed DMC

• 1 other identifier: CDC-NCZVED-5628
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 2

Brief Summary

In this stdy, patients aged above 6 months with symptomatic malaria presenting to health centers will be enrolled for treatment with artemether-lumefantrine for P. falciparum infection, and either artemether-lumefantrine or chloroquine for P. vivax infection. Clinical, parasitologic, and hematologic parameters will be monitored for P. falciparum and P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug efficacy. Results from this research study will be used to assist Ethiopia in assessing their current national malaria drug policies.

Conditions

Malaria

Keywords

malaria; therapeutic efficacy; in vivo; artemether lumefantrine; coartem; chloroquine; Plasmodium falciparum; Plasmodium vivax

Outcome Measures

Primary Outcomes (1)

• Determine Early Treatment Failures, Late Clinical Failures, Late Parasitological Failures, or Adequate Clinical and Parasitological Response during 28 days of follow-up for P. falciparum. Measure the treatment failure of AL and CQ for P. vivax

  28 days

Secondary Outcomes (1)

• Determine Early Treatment Failures, Late Clinical Failures, Late Parasitological Failures, or Adequate Clinical and Parasitological Response during 42 days of follow-up for P. falciparum. Measure the treatment failure of AL and CQ for P. vivax durin

  42 days

Study Arms (3)

Chloroquine-P. vivax

EXPERIMENTAL

P. vivax randomized to receive chloroquine 3-day regimen

Drug: Chloroquine- P. vivax

Artemether-Lumefantrine: P. vivax

EXPERIMENTAL

Drug: Artemether-Lumefantrine: P. vivax

Artemether-lumefantrine: P. falciparum

EXPERIMENTAL

administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage

Drug: Artemether-lumefantrine: P. falciparum

Interventions

Chloroquine- P. vivax DRUG

Total of 25mg base per kg over 3 days (10 mg base/kg on Days 1 and 2, and 5 mg base/kg on Day 3)

Chloroquine-P. vivax

Artemether-Lumefantrine: P. vivax DRUG

administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage

Artemether-Lumefantrine: P. vivax

Artemether-lumefantrine: P. falciparum DRUG

administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage

Artemether-lumefantrine: P. falciparum

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Slide-confirmed infection with P. falciparum, with parasitemia of 1,000-100,000 asexual forms/ μl or slide confirmed infection with P. vivax with \> 250 asexual forms/ μl
• Lives within 20 km of the enrolling health facility
• Weight ≥ 5.0 kg
• Axillary temperature ≥ 37.5º C or history of fever during the previous 24 or 48 hours for P. falciparum and P. vivax infection, respectively
• Patient or caregiver agrees to all blood draws and return visits.

You may not qualify if:

• 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 (NCHS/WHO normalized reference values;
• Slide confirmed infection with any other Plasmodium spp. besides falciparum/vivax or mixed plasmodium infection
• Severe anemia, defined as Hg \< 5 g/dl
• Known hypersensitivity to any of the drugs being evaluated
• Presence of febrile conditions caused by diseases other than malaria
• Serious or chronic medical condition (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
• Pregnant or breastfeeding women.
• Children weighing less than 5 kilograms.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• United States Agency for International Development (USAID): collaborator
• Columbia University: collaborator

Study Sites (2)

DebreZeit Malaria Center

Debrezeit, Oromiya, Ethiopia

Location

Bulbula Health Center

Zeway, Oromiya, Ethiopia

Location

Related Publications (2)

• Hwang J, Alemayehu BH, Reithinger R, Tekleyohannes SG, Takele Teshi, Birhanu SG, Demeke L, Hoos D, Melaku Z, Kassa M, Jima D, Malone JL, Nettey H, Green M, Poe A, Akinyi S, Udhayakumar V, Kachur SP, Filler S. In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia. PLoS One. 2013 May 22;8(5):e63433. doi: 10.1371/journal.pone.0063433. Print 2013.

  PMID: 23717423 DERIVED

• Hwang J, Alemayehu BH, Hoos D, Melaku Z, Tekleyohannes SG, Teshi T, Birhanu SG, Demeke L, Gobena K, Kassa M, Jima D, Reithinger R, Nettey H, Green M, Malone JL, Kachur SP, Filler S. In vivo efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria in Central Ethiopia. Malar J. 2011 Jul 28;10:209. doi: 10.1186/1475-2875-10-209.

  PMID: 21798054 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Malaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Jimee Hwang, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 17, 2010
• First Posted: January 20, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

ET (2)