MalariaNCT01511601
Apheresis to Obtain Plasma and White Blood Cells in Malies
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
Background: Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Malaria
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2011to 28 Jul 2016
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals 18-55 years of age are eligible to enter the study if they:
- Are enrolled on another NIAID/FMPOS-approved protocol.
- Weigh greater than or equal to 50 kg.
- Agree to have blood specimens stored for future studies.
- Agree to undergo genetic testing.
- Agree to undergo HIV, hepatitis B, and hepatitis C virus testing.
Who cannot join
- The following criteria are exclusionary:
- Positive at screening for HIV, hepatitis B, and/or hepatitis C.
- Cardiovascular instability (blood pressure <90/50 or >180/100; pulse <40 or >110.
- Inadequate peripheral venous access.
- Anemia (hemoglobin <11 g/dL).
- Current use of corticosteroids or other immunosuppressants.
Show all 9Show fewer
- Underlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis.
- Temperature greater than or equal to 37.5 degree C or other clinical evidence of an acute infection.
- Currently pregnant or breastfeeding.
About this study
Official title: Apheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies
Background:
- Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Healthy volunteers who provide plasma and white blood cells for study may need to give multiple donations. Researchers want to use apheresis to collect plasma and white blood cells from healthy volunteers in Mali.
Read more
Objectives:
- To collect plasma and white blood cells from healthy volunteers in Mali.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
- Volunteers must be in National Institute of Allergy and Infectious Diseases clinical trials.
Design:
- Participants will be screened with a physical exam and medical history. They will also provide basic blood and urine samples.
- Participants will have apheresis to collect plasma and white blood cells for study. Before each collection, they will provide a small blood sample for testing. They will be monitored during and after donation to prevent side effects.
- Under this protocol, participants may have apheresis up to six times per year.
- No treatment will be provided as part of this protocol....
Read the detailed description
To carry out in vitro research procedures on plasma or leukocyte components of whole blood, it is often necessary to obtain larger quantities of plasma or leukocytes than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using a well-established standard apheresis procedure that is in common use at the National Institutes of Health Apheresis Unit. This protocol describes the implementation of the same apheresis procedure at the National Blood Transfusion Center in Bamako, Mali. This is not a research protocol per se, but rather an adjunct protocol which allows healthy donors 18-55 years of age to undergo apheresis. Subjects must already be enrolled in another protocol which has been approved by the National Institute of Allergy and Infectious Diseases Institutional Review Board and the Faculty of Medicine, Pharmacy, and Odonto-Stomatology Ethics Committee.
- Conditions
- Malaria
- Keywords
- Apheresis, Leukocytes, Plasma, Plamodium Falciparum Malaria, Immunology
- Medical subject headings
- Malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study start20 Dec 2011
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter D Crompton, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511601
- Sponsor's protocol ID
- 999912048
- Other IDs
- 12-I-N048
- Status last verified
- 28 Jul 2016
- First submitted
- 13 Jan 2012
- Last updated
- 16 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies
- ClinicalTrials.gov ID
- NCT01511601
- Acronym / sponsor ID
- 999912048
- Conditions
- Malaria
- Keywords
- Apheresis, Leukocytes, Plasma, Plamodium Falciparum Malaria, Immunology
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Dec 2011
- Study completion
- 28 Jul 2016
- First posted
- 18 Jan 2012 (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.
Background:
- Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Healthy volunteers who provide plasma and white blood cells for study may need to give multiple donations. Researchers want to use apheresis to collect plasma and white blood cells from healthy volunteers in Mali.
Objectives:
- To collect plasma and white blood cells from healthy volunteers in Mali.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
- Volunteers must be in National Institute of Allergy and Infectious Diseases clinical trials.
Design:
- Participants will be screened with a physical exam and medical history. They will also provide basic blood and urine samples.
- Participants will have apheresis to collect plasma and white blood cells for study. Before each collection, they will provide a small blood sample for testing. They will be monitored during and after donation to prevent side effects.
- Under this protocol, participants may have apheresis up to six times per year.
- No treatment will be provided as part of this protocol....
Detailed description
To carry out in vitro research procedures on plasma or leukocyte components of whole blood, it is often necessary to obtain larger quantities of plasma or leukocytes than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using a well-established standard apheresis procedure that is in common use at the National Institutes of Health Apheresis Unit. This protocol describes the implementation of the same apheresis procedure at the National Blood Transfusion Center in Bamako, Mali. This is not a research protocol per se, but rather an adjunct protocol which allows healthy donors 18-55 years of age to undergo apheresis. Subjects must already be enrolled in another protocol which has been approved by the National Institute of Allergy and Infectious Diseases Institutional Review Board and the Faculty of Medicine, Pharmacy, and Odonto-Stomatology Ethics Committee.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are enrolled on another NIAID/FMPOS-approved protocol.
- Weigh greater than or equal to 50 kg.
- Agree to have blood specimens stored for future studies.
- Agree to undergo genetic testing.
- Agree to undergo HIV, hepatitis B, and hepatitis C virus testing.
Key exclusion criteria (9 listed)
- Positive at screening for HIV, hepatitis B, and/or hepatitis C.
- Cardiovascular instability (blood pressure <90/50 or >180/100; pulse <40 or >110.
- Inadequate peripheral venous access.
- Anemia (hemoglobin <11 g/dL).
- Current use of corticosteroids or other immunosuppressants.
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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.
Peter D Crompton, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 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: withdrawn, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 Dec 2019.