MalariaPhase 4NCT01814423
Pharmacokinetic Study of Multi-dose Chloroquine
A Phase 4 study testing Chloroquine-base 50 mg and Chloroquine-base 70 mg in people with Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Malaria
- What is being tested?
- Chloroquine-base 50 mg and Chloroquine-base 70 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Apr 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Malaria
- Being tested
- Chloroquine-base 50 mg, Chloroquine-base 70 mg
- Keywords
- Plasmodium falciparum, malaria, chloroquine, pharmacokinetic, children
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine-base 50 mgDrug
Chloroquine-base 70 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine-base 50 mg | Experimental | Chloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another day. Receives: Drug: Chloroquine-base 50 mg |
| Chloroquine-base 70 mg | Active comparator | Chloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another 3 days. Receives: Drug: Chloroquine-base 70 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chloroquine serum concentration
Filterpaper blood samples will be collected in the morning and evening on the days of treatment. On day 1 hourly during daytime.
Measured: Twice daily during treatment, on day 1 an additional 8 measurements.
Secondary outcomes (1)
Parasitemia
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.
Measured: Twice a day dúring treatment and then weekly until day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poul-Erik Kofoed, Ph.d, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814423
- Sponsor's protocol ID
- 2013-CQ
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2013
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ursing J, Rombo L, Eksborg S, Larson L, Bruvoll A, Tarning J, Rodrigues A, Kofoed PE. High-Dose Chloroquine for Uncomplicated Plasmodium falciparum Malaria Is Well Tolerated and Causes Similar QT Interval Prolongation as Standard-Dose Chloroquine in Children. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01846-19. doi: 10.1128/AAC.01846-19. Print 2020 Feb 21.
PubMed 31907183
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Multi-dose Chloroquine
- ClinicalTrials.gov ID
- NCT01814423
- Acronym / sponsor ID
- 2013-CQ
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, malaria, chloroquine, pharmacokinetic, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine-base 50 mg | Experimental | Drug: Chloroquine-base 50 mgChloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another day. |
| Chloroquine-base 70 mg | Active comparator | Drug: Chloroquine-base 70 mgChloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another 3 days. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroquine-base 50 mg | Drug | Chloroquine-base 50 mg |
| Chloroquine-base 70 mg | Drug | Chloroquine-base 70 mg |
Primary outcome
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.
1 secondary outcome
Parasitemia
Time frame: Twice a day dúring treatment and then weekly until day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Derived from this study: PubMed 31907183Ursing J, Rombo L, Eksborg S, Larson L, Bruvoll A, Tarning J, Rodrigues A, Kofoed PE. High-Dose Chloroquine for Uncomplicated Plasmodium falciparum Malaria Is Well Tolerated and Causes Similar QT Interval Prolongation as Standard-Dose Chloroquine in Children. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01846-19. doi: 10.1128/AAC.01846-19. Print 2020 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poul-Erik Kofoed, Ph.d principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine-base 50 mg and Chloroquine-base 70 mg in people with Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chloroquine serum concentration (time frame: Twice daily during treatment, on day 1 an additional 8 measurements.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.