Ethiopia Malaria Therapeutic Efficacy Study

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052584
• Other study ID #: CDC-NCZVED-5628
• Status: Completed
• Phase: N/A
• First received: January 17, 2010
• Last updated: November 17, 2010
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Malaria

Intervention

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)
• 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
• 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

Locations

Country	Name	City	State
Ethiopia	DebreZeit Malaria Center	Debrezeit	Oromia
Ethiopia	Bulbula Health Center	Zeway	Oromia

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Columbia University, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes