NCT00229775

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

5 years

First QC Date

September 28, 2005

Last Update Submit

September 10, 2012

Conditions

Malaria

Keywords

Plasmodium falciparum malariamalariaartemether lumafantrinechloroquinesulfadoxine pyrimethamineCoartem

Outcome Measures

Primary Outcomes (1)

  • Clinical cure

Secondary Outcomes (1)

  • Hemoglobin levels

Interventions

artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kalinga Health Center

Tabuk, Kalinga Province, Philippines

Location

Davao Health Center

Davao City, Mindinao, Philippines

Location

Palawan Health Center

Puerto Princesa City, Palawan, Philippines

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

Artemether

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Dorin Bustos, MD, PhD

    RITM, DOH, Philippines

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

PH(3)