MalariaNCT00127998
Antimalarial Drug Resistance in Mali
A study testing chloroquine, sulfadoxine-pyrimethamine and amodiaquine in people with Malaria, run by Centers for Disease Control and Prevention at 3 sites in Mali.
Trial summary
Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- chloroquine, sulfadoxine-pyrimethamine and amodiaquine
- How many people
- 1,011 participants
- Where
- 3 sitesMali
- Study dates
- Jul 2005to not given
- Phase
- Interventional
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-59 months
- Absence of severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of World Health Organization (WHO) reference values, or who has symmetrical edema involving at least the feet)
- A slide-confirmed infection with P. falciparum only (i.e. no mixed infections)
- Initial parasite density between 2,000 and 200,000 asexual parasites per microliter.
- Absence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
- Measured axillary temperature ≥ 37.5 °C
Show all 9Show fewer
- Ability to attend stipulated follow-up visits
- Informed consent provided by parent/guardian
- Absence of history of hypersensitivity reactions to any of the drugs being evaluated
Who cannot join
- Aged < 6 or >59 months
- Severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of WHO reference values, or who has symmetrical edema involving at least the feet)
- No slide confirmed infection with P. falciparum or a mixed infection that includes a non P. falciparum species
- Initial parasite density < 2,000 or > 200,000 asexual parasites per microliter.
- Presence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
- Measured axillary temperature <37.5 °C
Show all 9Show fewer
- Inability to attend stipulated follow-up visits
- Unwilling to provide informed consent provided by parent/guardian
- History of hypersensitivity reactions to any of the drugs being evaluated
Trial locations and contacts
3 sites in 1 country.
Mali3 sites
Faladje Missionary Dispensary
Faladié
Koro Health Center
Koro
Pongono Community Health Center
Pongono
About this study
Official title: Characterization of Novel Molecular Tools for the Epidemiological Surveillance of Antimalarial Drug Resistance in Mali
Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to:
- Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested.
- Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria
- Measure drug levels at 3 days and correlate with efficacy results.
- Examine early clinical, parasitologic, and clinical predictors of late treatment failure.
- Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
Read the detailed description
Resistance of Plasmodium falciparum to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Parasite populations are highly resistant to chloroquine on an almost worldwide basis (Central America and Haiti being the exceptions) and resistance to the next line of treatment, SP, is widespread in Asia and large parts of East Africa and South America. SP is also now recommended for use as intermittent preventative treatment (IPT) in pregnancy, which adds to concerns about the development and spread of SP resistance. More expensive combination drug therapy using artesunate and other antimalarials in combination is increasingly being recommended in an effort to extend the useful life of drugs and to slow the spread of antimalarial drug resistance. In all likelihood, resistance will eventually emerge for any new single drug or combination formulation that we deploy in the field.
Given the above, efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Such methods would help malaria control and prevention programs in guiding national treatment recommendations and policies. Integrating laboratory expertise, analytic methods based on population genetics, and more traditional methods of surveillance for anti-malarial drug resistance (e.g. in vivo drug efficacy studies) and networking with national and international partners will result in a multidisciplinary, geographically diverse team approach to assessing and monitoring drug resistant malaria, as well as developing and validating molecular methods. This type of effort will greatly assist in maximizing the useful life span of antimalarial drugs and in providing evidence-based guidance for drug policy decisions.
Specific Aims:
- Prospectively measure the in vivo response of P. falciparum malaria in Mali to CQ, SP, AQ, SP/AQ in combination, AQ/artesunate (AS) in combination, SP/AS, and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to MQ, MQ will also be tested.
- Measure the frequencies of dihydrofolate reductase (dhfr), dihydropteroate synthetase (dhps), P. falciparum chloroquine resistance transporter (pfcrt) and P. falciparum multi-drug resistant (pfmdr 1) genotypes and establish their relationship with in vivo resistance to SP (dhfr and dhps), CQ, AQ, SP/AQ, AQ/AS, SP/AS, and MQ.
- Measure drug levels at 3 days and correlate with in vivo efficacy results.
- Examine early clinical, parasitologic, and clinical predictors of late treatment failure.
- Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for SP, AQ, and MQ.
Study Design:
The study will entail two consecutive years of prospective 28 day in vivo drug efficacy studies carried out during the rainy season in three different malaria transmission sites: Koro (rural town with 71% of resistance to MQ at a lower dose of 15 mg/kg), Pongono (rural town with little exposure to antimalarials) and Faladje (rural village with > 30% of chloroquine resistance). Children aged 6-59 months with clinical symptoms consistent with malaria will be enrolled in the study after screening for fever (axillary temperature >=37.5 C) and malaria asexual parasites identified by microscopic examination of thick blood films.
Blood spotted onto filter papers will be collected prior to treatment and during follow up. These filter paper samples will be used for the molecular detection of drug resistance-conferring gene polymorphisms as well as the HPLC detection and quantification of the respective drugs and their relevant metabolites. In vivo data interpretation will be done using the WHO 28-day protocol (WHO, 2003) and molecular markers will be used for the determination of the genotype resistance index (GRI). Venous blood will be collected at enrollment and at the time of in vivo failure to measure in vitro drug efficacy and cryopreserve parasites to search for novel molecular markers to new antimalarial drugs.
- Conditions
- Malaria
- Being tested
- chloroquine, sulfadoxine-pyrimethamine, amodiaquine, amodiaquine+artesunate, amodiaquine+sulfadoxine-pyrimethamine
- Keywords
- malaria, Plasmodium falciparum, drug resistance, antimalarials, genotype, treatment outcome
- 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.
chloroquineDrug
sulfadoxine-pyrimethamineDrug
amodiaquineDrug
amodiaquine+artesunateDrug
amodiaquine+sulfadoxine-pyrimethamineDrug
sulfadoxine-pyrimethamine+artesunateDrug
artemether-lumefantrineDrug
mefloquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Failure (ETF, defined as: Development of danger signs or severe malaria on Day 1, 2, or 3, in the presence of parasitemia
Parasitemia on Day 2 higher than Day 0 count irrespective of axillary temperature
Parasitemia on Day 3 with axillary temperature ≥37.5°C
Parasitemia on Day 3 ≥ 25% of count on Day 0
Late Clinical Failure (LCF), defined as: Development of danger signs or severe malaria from Day 4 to Day 28 in the presence of parasitemia, without previously meeting any of the criteria of ETF
Presence of parasitemia and axillary temperature ≥37.5° C on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF
Late parasitological failure (LPF), defined as: Presence of parasitemia on Day 14 to Day 28 and axillary temperature <37.5°C without previously meeting any of the criteria of ETF or LCF
Adequate Clinical and Parasitological Response (ACPR), defined as: Absence of parasitemia on Day 28 irrespective of axillary temperature, without previously meeting any of the criteria of ETF, LCF or LPF
Secondary outcomes (2)
Frequencies of dhfr, dhps, pfcrt and pfmdr1 P. falciparum genotypes and relationship with in vivo resistance to SP (dhfr and dhps), CQ, AQ, SP/AQ, AQ/AS, SP/AS, and MQ
Drug levels at 3 days and correlation with in vivo efficacy results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,011 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Malaria Research and Training Center, Bamako, Mali
- Investigators
- Robert D. Newman, MD, MPH, Principal investigator, Centers for Disease Control and PreventionKassoum Kayentao, MD, MSPH, Principal investigator, Malaria Research and Training Center, Bamako, MaliJohn Barnwell, PhD, MPH, Principal investigator, Centers for Disease Control and PreventionOgobara Doumbo, MD, PhD, Principal investigator, Malaria Research and Training Center, Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127998
- Sponsor's protocol ID
- CDC-NCID-4314
- Status last verified
- Aug 2006
- First submitted
- 7 Jul 2005
- Last updated
- 16 Aug 2006
- Results posted
- No
Publications
WHO. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. Geneva: World Health Organization, 2003
Plowe CV. Monitoring antimalarial drug resistance: making the most of the tools at hand. J Exp Biol. 2003 Nov;206(Pt 21):3745-52. doi: 10.1242/jeb.00658.
PubMed 14506209Wernsdorfer WH, Noedl H. Molecular markers for drug resistance in malaria: use in treatment, diagnosis and epidemiology. Curr Opin Infect Dis. 2003 Dec;16(6):553-8. doi: 10.1097/00001432-200312000-00007.
PubMed 14624105Djimde A, Doumbo OK, Steketee RW, Plowe CV. Application of a molecular marker for surveillance of chloroquine-resistant falciparum malaria. Lancet. 2001 Sep 15;358(9285):890-1. doi: 10.1016/S0140-6736(01)06040-8. No abstract available.
PubMed 11567708Djimde A, Doumbo OK, Cortese JF, Kayentao K, Doumbo S, Diourte Y, Coulibaly D, Dicko A, Su XZ, Nomura T, Fidock DA, Wellems TE, Plowe CV. A molecular marker for chloroquine-resistant falciparum malaria. N Engl J Med. 2001 Jan 25;344(4):257-63. doi: 10.1056/NEJM200101253440403.
PubMed 11172152
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Novel Molecular Tools for the Epidemiological Surveillance of Antimalarial Drug Resistance in Mali
- ClinicalTrials.gov ID
- NCT00127998
- Acronym / sponsor ID
- CDC-NCID-4314
- Conditions
- Malaria
- Keywords
- malaria, Plasmodium falciparum, drug resistance, antimalarials, genotype, treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Malaria Research and Training Center, Bamako, Mali
- Study start
- Jul 2005
- First posted
- 9 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.
Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to:
- Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested.
- Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria
- Measure drug levels at 3 days and correlate with efficacy results.
- Examine early clinical, parasitologic, and clinical predictors of late treatment failure.
- Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
Detailed description
Resistance of Plasmodium falciparum to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Parasite populations are highly resistant to chloroquine on an almost worldwide basis (Central America and Haiti being the exceptions) and resistance to the next line of treatment, SP, is widespread in Asia and large parts of East Africa and South America. SP is also now recommended for use as intermittent preventative treatment (IPT) in pregnancy, which adds to concerns about the development and spread of SP resistance. More expensive combination drug therapy using artesunate and other antimalarials in combination is increasingly being recommended in an effort to extend the useful life of drugs and to slow the spread of antimalarial drug resistance. In all likelihood, resistance will eventually emerge for any new single drug or combination formulation that we deploy in the field.
Given the above, efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Such methods would help malaria control and prevention programs in guiding national treatment recommendations and policies. Integrating laboratory expertise, analytic methods based on population genetics, and more traditional methods of surveillance for anti-malarial drug resistance (e.g. in vivo drug efficacy studies) and networking with national and international partners will result in a multidisciplinary, geographically diverse team approach to assessing and monitoring drug resistant malaria, as well as developing and validating molecular methods. This type of effort will greatly assist in maximizing the useful life span of antimalarial drugs and in providing evidence-based guidance for drug policy decisions.
Specific Aims:
- Prospectively measure the in vivo response of P. falciparum malaria in Mali to CQ, SP, AQ, SP/AQ in combination, AQ/artesunate (AS) in combination, SP/AS, and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to MQ, MQ will also be tested.
- Measure the frequencies of dihydrofolate reductase (dhfr), dihydropteroate synthetase (dhps), P. falciparum chloroquine resistance transporter (pfcrt) and P. falciparum multi-drug resistant (pfmdr 1) genotypes and establish their relationship with in vivo resistance to SP (dhfr and dhps), CQ, AQ, SP/AQ, AQ/AS, SP/AS, and MQ.
- Measure drug levels at 3 days and correlate with in vivo efficacy results.
- Examine early clinical, parasitologic, and clinical predictors of late treatment failure.
- Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for SP, AQ, and MQ.
Study Design:
The study will entail two consecutive years of prospective 28 day in vivo drug efficacy studies carried out during the rainy season in three different malaria transmission sites: Koro (rural town with 71% of resistance to MQ at a lower dose of 15 mg/kg), Pongono (rural town with little exposure to antimalarials) and Faladje (rural village with > 30% of chloroquine resistance). Children aged 6-59 months with clinical symptoms consistent with malaria will be enrolled in the study after screening for fever (axillary temperature >=37.5 C) and malaria asexual parasites identified by microscopic examination of thick blood films.
Blood spotted onto filter papers will be collected prior to treatment and during follow up. These filter paper samples will be used for the molecular detection of drug resistance-conferring gene polymorphisms as well as the HPLC detection and quantification of the respective drugs and their relevant metabolites. In vivo data interpretation will be done using the WHO 28-day protocol (WHO, 2003) and molecular markers will be used for the determination of the genotype resistance index (GRI). Venous blood will be collected at enrollment and at the time of in vivo failure to measure in vitro drug efficacy and cryopreserve parasites to search for novel molecular markers to new antimalarial drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged 6-59 months
- Absence of severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of World Health Organization (WHO) reference values, or who has symmetrical edema involving at least the feet)
- A slide-confirmed infection with P. falciparum only (i.e. no mixed infections)
- Initial parasite density between 2,000 and 200,000 asexual parasites per microliter.
- Absence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
Key exclusion criteria (9 listed)
- Aged < 6 or >59 months
- Severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of WHO reference values, or who has symmetrical edema involving at least the feet)
- No slide confirmed infection with P. falciparum or a mixed infection that includes a non P. falciparum species
- Initial parasite density < 2,000 or > 200,000 asexual parasites per microliter.
- Presence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions
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 | – |
| sulfadoxine-pyrimethamine | Drug | – |
| amodiaquine | Drug | – |
| amodiaquine+artesunate | Drug | – |
| amodiaquine+sulfadoxine-pyrimethamine | Drug | – |
| sulfadoxine-pyrimethamine+artesunate | Drug | – |
| artemether-lumefantrine | Drug | – |
| mefloquine | Drug | – |
Primary outcome
Early Treatment Failure (ETF, defined as: Development of danger signs or severe malaria on Day 1, 2, or 3, in the presence of parasitemia
Parasitemia on Day 2 higher than Day 0 count irrespective of axillary temperature
Parasitemia on Day 3 with axillary temperature ≥37.5°C
Parasitemia on Day 3 ≥ 25% of count on Day 0
Late Clinical Failure (LCF), defined as: Development of danger signs or severe malaria from Day 4 to Day 28 in the presence of parasitemia, without previously meeting any of the criteria of ETF
Presence of parasitemia and axillary temperature ≥37.5° C on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF
Late parasitological failure (LPF), defined as: Presence of parasitemia on Day 14 to Day 28 and axillary temperature <37.5°C without previously meeting any of the criteria of ETF or LCF
Adequate Clinical and Parasitological Response (ACPR), defined as: Absence of parasitemia on Day 28 irrespective of axillary temperature, without previously meeting any of the criteria of ETF, LCF or LPF
2 secondary outcomes
Frequencies of dhfr, dhps, pfcrt and pfmdr1 P. falciparum genotypes and relationship with in vivo resistance to SP (dhfr and dhps), CQ, AQ, SP/AQ, AQ/AS, SP/AS, and MQ
Drug levels at 3 days and correlation with in vivo efficacy results
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 16 Aug 2006.
- BackgroundWHO. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. Geneva: World Health Organization, 2003
- Background: PubMed 14506209Plowe CV. Monitoring antimalarial drug resistance: making the most of the tools at hand. J Exp Biol. 2003 Nov;206(Pt 21):3745-52. doi: 10.1242/jeb.00658.
- Background: PubMed 14624105Wernsdorfer WH, Noedl H. Molecular markers for drug resistance in malaria: use in treatment, diagnosis and epidemiology. Curr Opin Infect Dis. 2003 Dec;16(6):553-8. doi: 10.1097/00001432-200312000-00007.
- Background: PubMed 11567708Djimde A, Doumbo OK, Steketee RW, Plowe CV. Application of a molecular marker for surveillance of chloroquine-resistant falciparum malaria. Lancet. 2001 Sep 15;358(9285):890-1. doi: 10.1016/S0140-6736(01)06040-8. No abstract available.
- Background: PubMed 11172152Djimde A, Doumbo OK, Cortese JF, Kayentao K, Doumbo S, Diourte Y, Coulibaly D, Dicko A, Su XZ, Nomura T, Fidock DA, Wellems TE, Plowe CV. A molecular marker for chloroquine-resistant falciparum malaria. N Engl J Med. 2001 Jan 25;344(4):257-63. doi: 10.1056/NEJM200101253440403.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Robert D. Newman, MD, MPH principal investigator
Centers for Disease Control and Prevention
Kassoum Kayentao, MD, MSPH principal investigator
Malaria Research and Training Center, Bamako, Mali
John Barnwell, PhD, MPH principal investigator
Centers for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chloroquine, sulfadoxine-pyrimethamine and amodiaquine in people with Malaria, run by Centers for Disease Control and Prevention at 3 sites in Mali.
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 9 inclusion and 9 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 16 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mali. 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.
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?
Early Treatment Failure (ETF, defined as: Development of danger signs or severe malaria on Day 1, 2, or 3, in the presence of parasitemia. The study lists 8 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 NCT00127998, which also lists 5 linked publications.
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 16 Aug 2006.