Anemia Clinical Trial - Malaria Incidence in Infants in Bancoumana, Mali

Status Completed

Clinical 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.

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00508417
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	N/A
Start date	July 24, 2007
Completion date	February 11, 2011

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03341338` - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed	`NCT00060398` - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer	Phase 3
Recruiting	`NCT05384691` - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	Phase 2
Not yet recruiting	`NCT06309641` - Methemoglobinemia Following Intravenous Iron Treatment
Completed	`NCT02912494` - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02930850` - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation	N/A
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT03822884` - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers	Phase 1
Completed	`NCT02912533` - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02603250` - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda	N/A
Completed	`NCT02384122` - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias	Phase 3
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Withdrawn	`NCT01934842` - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate	N/A
Completed	`NCT02310113` - Transfusion and Skeletal Muscle Tissue Oxygenation	N/A
Completed	`NCT01922479` - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure	Phase 4
Completed	`NCT01693029` - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa	Phase 3
Completed	`NCT01432717` - Study of ACE-536 in Healthy Postmenopausal Women	Phase 1
Terminated	`NCT01535781` - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.