Malaria, FalciparumPhase 4NCT00137514
Chloroquine and Amodiaquine for Treatment of Malaria in Children
A Phase 4 study testing chloroquine and amodiaquine in people with Malaria, Falciparum, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
This study will evaluate the efficacy of the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance will be examined. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- chloroquine and amodiaquine
- How many people
- 720 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Mar 2001to May 2004
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients < 15 years of age presenting at Bandim Health Centre
- Symptoms suggestive of malaria
- At least 20 P. falciparum parasites per 200 leukocytes in a thick film
- Live in Bandim (to enable follow-up)
Who cannot join
- Severely ill children considered needing the services of a hospital by the medical doctor in charge
- Stated medication with other antimalarials within one week prior to treatment
- Previous idiosyncratic reactions to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chloroquine and Amodiaquine for Treatment of Symptomatic Children With Plasmodium Malaria in Guinea-Bissau
This study will evaluate the efficacy of the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a positive malaria test will be included. The children will be visited and malaria films will be obtained weekly until day 35. In case of a reappearance of parasites the children will be re-treated with sulfadoxine/pyrimethamine.
Read the detailed description
This study compares treatment of uncomplicated malaria in children in Guinea-Bissau as recommended by the national malaria programme (chloroquine in a total dose of 25 mg/kg), either with a total dose of 50 mg/kg chloroquine or with a total dose of 15 or 30 mg of amodiaquine. As both annual in vitro studies (from 1992 to 2004 except 1998, 1999) and several in-vivo studies from Guinea-Bissau indicate a fairly stable chloroquine resistance prevalence, another aim of this study is to evaluate the genetic basis of chloroquine resistance in Guinea-Bissau by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial.
Following consent to participate, children visiting the Bandim Health Centre on the outskirts of Bissau with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the four different treatment groups. The treatment is given supervised by one of the health workers. The children are visited and malaria films obtained on day 2 and day 7 and then once weekly until day 35. On day seven, 100 microliters of capillary blood are drawn for analyses of chloroquine or amodiaquine concentrations in whole blood. Whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis.
If parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. During the study parents are recommended to bring the child to Bandim Health Centre in case of any illness. Participating children will be examined and treated free of charge. Following the recommendations of the national Malaria Programme sulfadoxine/pyrimethamine will be used for re-treatment of children in case of recrudescence.
The results from this study could be used when giving the needed new recommendations for treatment of malaria in Guinea-Bissau. If still effective mono-therapy with a higher dose of chloroquine could be used until the introduction of a better treatment is possible. When artemisinine combination therapy is going to be introduced in Guinea-Bissau the results could be helpful in deciding if amodiaquine should be considered as the partner drug - and in which dose.
- Conditions
- Malaria, Falciparum
- Being tested
- chloroquine, amodiaquine
- Keywords
- malaria, Plasmodium falciparum, chloroquine, amodiaquine, treatment, Guinea-Bissau, children
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquineDrug
amodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite reappearance rate
hospitalization during follow-up
Secondary outcomes (3)
Genetic markers in parasites
recrudescence rate
re-infection rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMar 2001
- Primary completionMay 2004
- Study completionMay 2004
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 Malaria, FalciparumStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Investigators
- Peter Aaby, Study director, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137514
- Sponsor's protocol ID
- PSB-2001-chl-amo
- Other IDs
- 2004-126 (SAREC).
- Status last verified
- Apr 2008
- First submitted
- 28 Aug 2005
- Last updated
- 8 Apr 2008
- Results posted
- No
Publications
Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.
PubMed 25421474
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chloroquine and Amodiaquine for Treatment of Symptomatic Children With Plasmodium Malaria in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT00137514
- Acronym / sponsor ID
- PSB-2001-chl-amo
- Conditions
- Malaria, Falciparum
- Keywords
- malaria, Plasmodium falciparum, chloroquine, amodiaquine, treatment, Guinea-Bissau, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 30 Aug 2005 (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.
This study will evaluate the efficacy of the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a positive malaria test will be included. The children will be visited and malaria films will be obtained weekly until day 35. In case of a reappearance of parasites the children will be re-treated with sulfadoxine/pyrimethamine.
Detailed description
This study compares treatment of uncomplicated malaria in children in Guinea-Bissau as recommended by the national malaria programme (chloroquine in a total dose of 25 mg/kg), either with a total dose of 50 mg/kg chloroquine or with a total dose of 15 or 30 mg of amodiaquine. As both annual in vitro studies (from 1992 to 2004 except 1998, 1999) and several in-vivo studies from Guinea-Bissau indicate a fairly stable chloroquine resistance prevalence, another aim of this study is to evaluate the genetic basis of chloroquine resistance in Guinea-Bissau by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial.
Following consent to participate, children visiting the Bandim Health Centre on the outskirts of Bissau with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the four different treatment groups. The treatment is given supervised by one of the health workers. The children are visited and malaria films obtained on day 2 and day 7 and then once weekly until day 35. On day seven, 100 microliters of capillary blood are drawn for analyses of chloroquine or amodiaquine concentrations in whole blood. Whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis.
If parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. During the study parents are recommended to bring the child to Bandim Health Centre in case of any illness. Participating children will be examined and treated free of charge. Following the recommendations of the national Malaria Programme sulfadoxine/pyrimethamine will be used for re-treatment of children in case of recrudescence.
The results from this study could be used when giving the needed new recommendations for treatment of malaria in Guinea-Bissau. If still effective mono-therapy with a higher dose of chloroquine could be used until the introduction of a better treatment is possible. When artemisinine combination therapy is going to be introduced in Guinea-Bissau the results could be helpful in deciding if amodiaquine should be considered as the partner drug - and in which dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients < 15 years of age presenting at Bandim Health Centre
- Symptoms suggestive of malaria
- At least 20 P. falciparum parasites per 200 leukocytes in a thick film
- Live in Bandim (to enable follow-up)
Key exclusion criteria (3 listed)
- Severely ill children considered needing the services of a hospital by the medical doctor in charge
- Stated medication with other antimalarials within one week prior to treatment
- Previous idiosyncratic reactions to any of the study drugs
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 | Drug | – |
| amodiaquine | Drug | – |
Primary outcome
Parasite reappearance rate
hospitalization during follow-up
3 secondary outcomes
Genetic markers in parasites
recrudescence rate
re-infection rate
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 8 Apr 2008.
- Derived from this study: PubMed 25421474Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.
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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.
Peter Aaby study director
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 and amodiaquine in people with Malaria, Falciparum, 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 4 inclusion and 3 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 8 Apr 2008. 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?
Parasite reappearance rate. The study lists 2 primary outcomes in all. 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 NCT00137514, 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 8 Apr 2008.