Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Philippines
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00229775
First received: September 28, 2005
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine whether artemether + lumefantrine is as effective as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria


Condition Intervention
Malaria
Drug: artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical cure

Secondary Outcome Measures:
  • Hemoglobin levels

Enrollment: 560
Study Start Date: July 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Background: In the Philippines, close to 11 million people in 65 provinces are at risk for acquiring malaria infections. It is still one of the ten leading causes of morbidity nationwide. Each day, roughly 150-200 people fall ill with malaria. In the past 40 years, the mortality rate stabilized at around 2/100,000 population. Of those people who have malaria, approximately 1% die per year. Malaria remains one of the major causes of death in provinces such as Palawan, Isabela, Tawi-tawi, Sulu and Butuan City. Approximately 70% of all malaria in the Philippines is Plasmodium falciparum with the remaining species being P. vivax.

Recently the Department of Health (DOH) instituted a change in the national antimalarial drug guidelines changing from using chloroquine (CQ) and sulfadoxine pyrimethamine (SP) monotherapy as first and second line drugs, respectively, to a combined chloroquine plus sulfadoxine-pyrimethamine as first-line treatment, and artemether-lumefantrine (Coartem) as second line treatment. This change was made due to increasing levels of drug resistance to the previous first and second-line therapies. In order to have an improved understanding of the trends of antimalarial drug resistance in the Philippines, the DOH is initiating a sentinel surveillance system for monitoring of antimalarial drug resistance. Three sites have been selected to be representative of the country.

Objective: To establish a sentinel surveillance system to assess the efficacy of chloroquine plus sulfadoxine-pyrimethamine versus artemether + lumefantrine for the treatment of uncomplicated P. falciparum infections in three areas of the Republic of the Philippines.

Methods: An in vivo antimalarial drug efficacy trial will be conducted in three areas of the Philippines. Subjects > 6 months of age with parasitologically confirmed, uncomplicated P. falciparum infections will be recruited. Patients will be treated with single dose SP (25 mg/kg of the sulfadoxine component in a single dose) plus CQ (25 mg/kg over three days) or artemether + lumefantrine (twice daily) over 3 days. Patients will be randomly assigned one of the two drugs regimens. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Results from this study will be used to assist the DOH in assessing their national malaria treatment policy for P. falciparum malaria.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Weight > 10 kg;
  2. Documented fever (axillary temperature >37.5oC) and/or a history of fever during the previous 24 hours in the absence of another obvious cause of fever (such as pneumonia, measles, otitis media);
  3. Monoinfection with P. falciparum between 1,000 and 100,000 asexual parasites/µl as determined by microscopic examination of thick, or thick and thin peripheral blood smears;
  4. Informed consent from the patient or parent/guardian (in the case of children),assent from child (ages 8 -17 years inclusive);
  5. Willingness on the part of the patient to return to the clinic for regular check-ups during the 28-day follow-up period.

Exclusion Criteria:

1. Danger signs: unable to drink or breastfeed; vomiting (more than twice in the previous 24 hours); recent history of convulsions (one or more in the previous 24 hours); impaired consciousness; unable to sit or stand; 2. Severe Manifestations of P. falciparum malaria in adults and children (World Health Organization criteria)

  1. Prostration (inability to sit unassisted [children], extreme weakness [adults])
  2. Impaired consciousness (Blantyre coma scale [children], Glascow coma scale [adults])
  3. Respiratory distress (sustained nasal flaring, indrawing, Kussmaul breathing)
  4. Multiple convulsions (³2 convulsions/24 hour period)
  5. Circulatory collapse (hypotension and poor perfusion)
  6. Pulmonary edema
  7. Abnormal bleeding
  8. Jaundice
  9. Hemoglobinuria
  10. Severe anemia (Hb < 5 gm/dL)
  11. Hypoglycemia (blood glucose < 2.2 mmol/L [<40 mg/dL])
  12. Acidosis (bicarbonate <15 mmol/L)
  13. Hyperparisitemia (level varies with endemicity)
  14. Renal impairment (urine output < 12 mL/kg/24 hours) 3. Other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, malnutrition); 4. History of hypersensitivity reactions to any of the drugs being tested or used as alternative treatment: sulfonamides, chloroquine, artemisinins, artemether, lumefantrine, quinine or tetracycline/clindamycin; 4. Pregnancy (history of pregnancy or a positive urine pregnancy test); 5. Women who are breast feeding children less than 8 weeks of age. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229775

Locations
Philippines
Kalinga Health Center
Tabuk, Kalinga Province, Philippines
Davao Health Center
Davao City, Mindinao, Philippines
Palawan Health Center
Puerto Princesa, Palawan, Philippines
Sponsors and Collaborators
Department of Health, Philippines
Investigators
Study Director: Dorin Bustos, MD, PhD RITM, DOH, Philippines
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00229775     History of Changes
Other Study ID Numbers: CDC-NCID-3913, U30/CCU317876-01
Study First Received: September 28, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Plasmodium falciparum malaria
malaria
artemether lumafantrine
chloroquine
sulfadoxine pyrimethamine
Coartem

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Artemether
Artemisinins
Sulfadoxine-pyrimethamine
Lumefantrine
Artemether-lumefantrine combination
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

ClinicalTrials.gov processed this record on April 21, 2014