Malaria InfectionNCT00508417
Malaria Incidence in Infants in Bancoumana, Mali
An observational study of Malaria Infection and Malaria Incidence, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines. Read more about this study
- Who is it for?
- Ages 6 weeks to 6 months
- Conditions the study is for
- Malaria Infection, Malaria Incidence, Anemia
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2007to 11 Feb 2011
- Phase
- Observational
- 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 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants at least six weeks to less than 7 months of age at enrollment
- Known residents of the Bancoumana health area
- Good general health as determined by clinical exam
- Available for the 6-7 months duration of the trial
- Willingness to participate as evidenced by signing of the informed consent or fingerprinting by the parent or guardian
Who cannot join
- Social, behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol
- Participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing
- Infant born to mother with known or suspected HIV/AIDS as determined by the clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, 20892
About this study
This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines.
Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests.
Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.
Read the detailed description
This is an observational study to determine the burden of malaria in rural Malian infants. Infants will be identified during a village-wide census and at Expanded Program for Immunization (EPI) visits. After obtaining community consent, eligible infants' parents will be invited to bring infants to the clinic for screening. Enrolled infants will receive a baseline evaluation and monthly visits during the rainy season at which times they will receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, malaria antibody titers (at first and last visit for each transmission season), and hemoglobin typing at one visit. Study subjects will also receive a weekly home visit to determine if they are well or ill. If ill or febrile at any visit, or if they present to the clinic for an unscheduled visit, subjects will receive a history and physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, filter paper blood collection and an RDT for malaria. Diagnosis and treatment of malaria will be performed according to Mali National Malaria Control Program (NMCP) guidelines. Diagnosis and treatment of other conditions will be performed as determined by the treating clinician.
- Conditions
- Malaria Infection, Malaria Incidence, Anemia
- Keywords
- Malaria Incidence, Anemia, Clinical Malaria
- Medical subject headings
- Anemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study start24 Jul 2007
- Study completion11 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malaria InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508417
- Sponsor's protocol ID
- 999907198
- Other IDs
- 07-I-N198
- Status last verified
- 11 Feb 2011
- First submitted
- 27 Jul 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Duflo B, Balique H, Ranque P, Diallo AN, Brucker G, Alavi H, Prescott N. [Estimation of the impact of the principal diseases in rural Mali]. Rev Epidemiol Sante Publique. 1986;34(6):405-18. French.
PubMed 3105007Wagner G, Koram K, McGuinness D, Bennett S, Nkrumah F, Riley E. High incidence of asymptomatic malara infections in a birth cohort of children less than one year of age in Ghana, detected by multicopy gene polymerase chain reaction. Am J Trop Med Hyg. 1998 Jul;59(1):115-23. doi: 10.4269/ajtmh.1998.59.115.
PubMed 9684638Moody AH, Chiodini PL. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. Br J Biomed Sci. 2002;59(4):228-31. doi: 10.1080/09674845.2002.11783665.
PubMed 12572958
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria Incidence in Infants in Bancoumana, Mali
- ClinicalTrials.gov ID
- NCT00508417
- Acronym / sponsor ID
- 999907198
- Conditions
- Malaria Infection, Malaria Incidence, Anemia
- Keywords
- Malaria Incidence, Anemia, Clinical Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Jul 2007
- Study completion
- 11 Feb 2011
- First posted
- 30 Jul 2007 (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, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines.
Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests.
Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.
Detailed description
This is an observational study to determine the burden of malaria in rural Malian infants. Infants will be identified during a village-wide census and at Expanded Program for Immunization (EPI) visits. After obtaining community consent, eligible infants' parents will be invited to bring infants to the clinic for screening. Enrolled infants will receive a baseline evaluation and monthly visits during the rainy season at which times they will receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, malaria antibody titers (at first and last visit for each transmission season), and hemoglobin typing at one visit. Study subjects will also receive a weekly home visit to determine if they are well or ill. If ill or febrile at any visit, or if they present to the clinic for an unscheduled visit, subjects will receive a history and physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, filter paper blood collection and an RDT for malaria. Diagnosis and treatment of malaria will be performed according to Mali National Malaria Control Program (NMCP) guidelines. Diagnosis and treatment of other conditions will be performed as determined by the treating clinician.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
- Social, behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol
- Participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing
- Infant born to mother with known or suspected HIV/AIDS as determined by the clinician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 3105007Duflo B, Balique H, Ranque P, Diallo AN, Brucker G, Alavi H, Prescott N. [Estimation of the impact of the principal diseases in rural Mali]. Rev Epidemiol Sante Publique. 1986;34(6):405-18. French.
- Background: PubMed 9684638Wagner G, Koram K, McGuinness D, Bennett S, Nkrumah F, Riley E. High incidence of asymptomatic malara infections in a birth cohort of children less than one year of age in Ghana, detected by multicopy gene polymerase chain reaction. Am J Trop Med Hyg. 1998 Jul;59(1):115-23. doi: 10.4269/ajtmh.1998.59.115.
- Background: PubMed 12572958Moody AH, Chiodini PL. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. Br J Biomed Sci. 2002;59(4):228-31. doi: 10.1080/09674845.2002.11783665.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria Infection and Malaria Incidence, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 5 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 2 Jul 2017. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508417, which also lists 3 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 2 Jul 2017.