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Pharmacokinetic Study of Multi-dose Chloroquine

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ClinicalTrials.gov Identifier: NCT01814423
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : March 11, 2014
Information provided by (Responsible Party):
Bandim Health Project

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 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and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Chloroquine-base 50 mg Drug: Chloroquine-base 70 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Multi-dose Chloroquine
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Chloroquine-base 50 mg
Chloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another day.
Drug: Chloroquine-base 50 mg
Active Comparator: Chloroquine-base 70 mg
Chloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another 3 days.
Drug: Chloroquine-base 70 mg

Primary Outcome Measures :
  1. Chloroquine serum concentration [ Time Frame: Twice daily during treatment, on day 1 an additional 8 measurements. ]
    Filterpaper blood samples will be collected in the morning and evening on the days of treatment. On day 1 hourly during daytime.

Secondary Outcome Measures :
  1. Parasitemia [ Time Frame: Twice a day dúring treatment and then weekly until day 28. ]
    Blood smear for microscopy will be performed in the morning and evening on the days of treatment, and for the 50 mg group on day 3. During follow-uo weekly until day 28.

Other Outcome Measures:
  1. Haemoglobin level [ Time Frame: On day 0, 3 and 28. ]
    The haemoglobin level will be measured on the the specified days.

  2. Blood pressure [ Time Frame: On day 1 and day 28 ]
    Will be measures on day 1 at midday and on day 28.

  3. ECG [ Time Frame: Will be measures on day 1 and on last treatment day. ]

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814423

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Projecto de Saúde de Bandim
Bissau, Guinea-Bissau, 1004
Sponsors and Collaborators
Bandim Health Project
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Principal Investigator: Poul-Erik Kofoed, Ph.d Bandim Health Project
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01814423    
Other Study ID Numbers: 2013-CQ
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Bandim Health Project:
Plasmodium falciparum
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents