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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: Department of Health, Philippines
• Treatments: Artemether; Artemether-lumefantrine combination; Artemisinins; Chloroquine; Chloroquine diphosphate; Fanasil, pyrimethamine drug combination; Lumefantrine; Pyrimethamine; Sulfadoxine

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. -