Pharmacokinetic Study of Multi-dose Chloroquine
Information source: Bandim Health Project
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Chloroquine-base 50 mg (Drug); Chloroquine-base 70 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bandim Health Project Official(s) and/or principal investigator(s):
Poul-Erik Kofoed, Ph.d, Principal Investigator, Affiliation: Bandim Health Project
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 well tolerated and safe. Still, safety could be an issue when the dose of
CQ is increased. Severe adverse events are caused by high peak concentrations of CQ. Using
split doses of CQ avoids high peak concentrations enabling the safe administration of high
doses, however, pharmacokinetic data are lacking.
Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg
as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse
events will be monitored. On day 1, children and their mother/guardian will be requested to
stay at the health centre between 9 am and 6 pm.
Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the
inclusion criteria will be recruited into each study arm.
Following the end of treatment, the children will be seen on the morning of day 7, 14, 21
and 28.
Any child wishing to withdraw during the treatment phase and any child with reparasitaemia
during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine
according to treatment guidelines in Guinea-Bissau.
Final analysis will include a description of included children, proportions of adverse
events and any serious adverse events, drug concentrations and their relation to adverse
events, the proportion of children withdrawn or lost to follow up, the cumulative PCR
corrected and uncorrected success and failure rates on day 28 and the proportion of early,
late clinical and late parasitological treatment failures.
Clinical Details
Official title: Pharmacokinetic Study of Multi-dose Chloroquine
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Chloroquine serum concentration
Secondary outcome: Parasitemia
Eligibility
Minimum age: 2 Years.
Maximum age: 9 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Projecto de Saúde de Bandim, Bissau 1004, Guinea-Bissau
Additional Information
Starting date: April 2013
Last updated: March 10, 2014
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