Status:
COMPLETED
Pharmacokinetic Study of Multi-dose Chloroquine
Lead Sponsor:
Bandim Health Project
Conditions:
Malaria
Eligibility:
All Genders
2-9 years
Phase:
PHASE4
Brief Summary
Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95% efficacy and was w...
Eligibility Criteria
Inclusion
- Age ≥ 2 years and \< 10 years.
- Mono-infection with P. falciparum detected by microscopy. Parasitemia of 1.000-100.000/µl asexual forms.
- Axillary temperature ≥ 37.5 ˚C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol.
- Informed consent from a parent or guardian
Exclusion
- Signs or symptoms of severe malaria.
- Presence of general danger signs in children under 5.
- Persistent vomiting.
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to chloroquine.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01814423
Start Date
April 1 2013
End Date
March 1 2014
Last Update
March 11 2014
Active Locations (1)
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1
Projecto de Saúde de Bandim
Bissau, Guinea-Bissau, 1004