Status:
COMPLETED
Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Department of Health, Philippines
Conditions:
Malaria
Eligibility:
All Genders
Phase:
NA
Brief Summary
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
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, ro...
Eligibility Criteria
Inclusion
- Weight \> 10 kg;
- 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);
- 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;
- Informed consent from the patient or parent/guardian (in the case of children),assent from child (ages 8 -17 years inclusive);
- Willingness on the part of the patient to return to the clinic for regular check-ups during the 28-day follow-up period.
Exclusion
- 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)
- Prostration (inability to sit unassisted \[children\], extreme weakness \[adults\])
- Impaired consciousness (Blantyre coma scale \[children\], Glascow coma scale \[adults\])
- Respiratory distress (sustained nasal flaring, indrawing, Kussmaul breathing)
- Multiple convulsions (³2 convulsions/24 hour period)
- Circulatory collapse (hypotension and poor perfusion)
- Pulmonary edema
- Abnormal bleeding
- Jaundice
- Hemoglobinuria
- Severe anemia (Hb \< 5 gm/dL)
- Hypoglycemia (blood glucose \< 2.2 mmol/L \[\<40 mg/dL\])
- Acidosis (bicarbonate \<15 mmol/L)
- Hyperparisitemia (level varies with endemicity)
- 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. -
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT00229775
Start Date
July 1 2003
End Date
July 1 2008
Last Update
September 11 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Kalinga Health Center
Tabuk, Kalinga Province, Philippines
2
Davao Health Center
Davao City, Mindinao, Philippines
3
Palawan Health Center
Puerto Princesa City, Palawan, Philippines