Ethiopia Malaria Therapeutic Efficacy Study
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| ClinicalTrials.gov Identifier: NCT01052584 |
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Recruitment Status :
Completed
First Posted : January 20, 2010
Last Update Posted : November 18, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malaria | Drug: Chloroquine- P. vivax Drug: Artemether-Lumefantrine: P. vivax Drug: Artemether-lumefantrine: P. falciparum | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 354 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | January 2010 |
| Actual Study Completion Date : | January 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chloroquine-P. vivax
P. vivax randomized to receive chloroquine 3-day regimen
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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 |
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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
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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 |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052584
| Ethiopia | |
| DebreZeit Malaria Center | |
| Debrezeit, Oromia, Ethiopia | |
| Bulbula Health Center | |
| Zeway, Oromia, Ethiopia | |
| Principal Investigator: | Jimee Hwang, MD | Centers for Disease Control and Prevention |
| Responsible Party: | Jimee Hwang/ Medical Epidemiologist, CDC |
| ClinicalTrials.gov Identifier: | NCT01052584 |
| Other Study ID Numbers: |
CDC-NCZVED-5628 |
| First Posted: | January 20, 2010 Key Record Dates |
| Last Update Posted: | November 18, 2010 |
| Last Verified: | November 2010 |
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malaria therapeutic efficacy in vivo artemether lumefantrine |
coartem chloroquine Plasmodium falciparum Plasmodium vivax |
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Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Chloroquine Lumefantrine Artemether |
Artemether, Lumefantrine Drug Combination Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents |