Ethiopia Malaria Therapeutic Efficacy Study

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Columbia University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01052584
First received: January 17, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Malaria
Drug: Chloroquine- P. vivax
Drug: Artemether-Lumefantrine: P. vivax
Drug: Artemether-lumefantrine: P. falciparum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ethiopia In-vivo Efficacy Study 2009: Evaluating the Efficacy of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Infection and Either Artemether-lumefantrine or Chloroquine for P. Vivax Infection

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Enrollment: 354
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chloroquine-P. vivax
P. vivax randomized to receive chloroquine 3-day regimen
Drug: Chloroquine- P. vivax
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)
Experimental: Artemether-Lumefantrine: P. vivax Drug: Artemether-Lumefantrine: P. vivax
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
Experimental: Artemether-lumefantrine: P. falciparum
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
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

Detailed Description:

Following the rapid development of significant drug resistance of Plasmodium falciparum (Pf) to chloroquine and then sulfadoxine-pyrimethamine (the first line therapy in Ethiopia 1998-2004), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Ethiopia in 2004. According to the current national malaria diagnosis and treatment guidelines, first-line treatment for uncomplicated falciparum infection is AL. First-line treatment for Plasmodium vivax (Pv) is with chloroquine (CQ) alone without primaquine therapy in malarious areas. For all clinical infection without laboratory confirmation, AL which is effective against both Pf and Pv is the first-line treatment. Thus, in Ethiopia, where treatment for malaria without laboratory confirmation occurs frequently, Pv is often treated with AL as the standard of care. Furthermore, World Health Organization (WHO) recommends AL for the treatment of Pv, where AL has been adopted as first-line treatment for Pf. Now with wide-spread use of AL and CQ, we propose to conduct an antimalarial efficacy study to monitor the effectiveness of these therapies in Ethiopia and to determine how efficacious these drugs remain. This information will inform future policy changes with respect to appropriate antimalarial strategies.

The simplest and most universally accepted measure of testing for antimalarial drug treatment efficacy, the standardized procedures outlined in the World Health Organization Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria and the WHO Monitoring antimalarial drug resistance, will be followed.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052584

Locations
Ethiopia
DebreZeit Malaria Center
Debrezeit, Oromia, Ethiopia
Bulbula Health Center
Zeway, Oromia, Ethiopia
Sponsors and Collaborators
United States Agency for International Development (USAID)
Columbia University
Investigators
Principal Investigator: Jimee Hwang, MD Centers for Disease Control and Prevention
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jimee Hwang/ Medical Epidemiologist, CDC
ClinicalTrials.gov Identifier: NCT01052584     History of Changes
Other Study ID Numbers: CDC-NCZVED-5628
Study First Received: January 17, 2010
Last Updated: November 17, 2010
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
malaria
therapeutic efficacy
in vivo
artemether lumefantrine
coartem
chloroquine
Plasmodium falciparum
Plasmodium vivax

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Artemether
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents
Antifungal Agents
Coccidiostats

ClinicalTrials.gov processed this record on September 18, 2014