Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Dorin Bustos, MD, PhD, Study Director, Affiliation: RITM, DOH, Philippines
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
Clinical Details
Official title: Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical cure
Secondary outcome: Hemoglobin levels
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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. -
Locations and Contacts
Kalinga Health Center, Tabuk, Kalinga Province, Philippines
Davao Health Center, Davao City, Mindinao, Philippines
Palawan Health Center, Puerto Princesa, Palawan, Philippines
Additional Information
Starting date: July 2003
Last updated: September 10, 2012
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