Plasmodium Falciparum MalariaCPMNCT00707200
The Cytoadherence in Pediatric Malaria (CPM) Study
An observational study of Plasmodium Falciparum Malaria, run by University Health Network, Toronto at 1 site in Uganda.
Trial summary
The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Plasmodium Falciparum Malaria
- How many people
- 2,000 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2007to Nov 2009
- 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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium falciparum parasitemia.
Who may be able to join
- Clinical diagnosis of Plasmodium falciparum malaria infection
Who cannot join
- HIV or significant malnutrition
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mulago Hospital Acute Care Unit & Makerere University Department of Paediatrics & Child Health
Kampala
About this study
Official title: Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors
The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children.
Read the detailed description
Every year, nearly 2 million children die from infection with Plasmodium falciparum malaria. When red blood cells (RBC) become infected with malaria, a sticky parasite-derived knob protein, termed PfEMP-1, erupts on the RBC surfaces. PfEMP-1 attaches to several blood group molecules, including those found on other RBC, on blood vessels, and on the cells that normally help to stop bleeding (platelets). The cellular sticking results in a dangerous interruption in blood flow to vital organs, causing brain injury (cerebral malaria), systemic shock (lactic acidosis), and death. Depending on an individual's inherited blood groups of relevance, adhesion may be extensive or limited. In the laboratory, PfEMP-1 adheres to RBCs via the A or B (but not the O) antigens of the ABO blood group system, and to platelets and blood vessels via platelet glycoprotein IV (CD36) and ICAM-1. Consistent with the expected evolutionary advantage of being deficient in these binding targets, blood type O and low-expression of CD36 are found more frequently among Africans. The "Cytoadherence in Pediatric Malaria" (CPM) project is determining the distribution of adhesive blood group molecules in a cohort of 2000 Ugandan children according to the extent of malaria severity and death, and thus their ultimate clinical and evolutionary significance in malarial survival. This knowledge may serve as the grounds for developing targeted cytoadhesion-interruption therapies in our fight against malaria.
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- severe malarial anemia (SMA), cerebral malarial (CM), lactic acidosis, hyperparasitemia, respiratory distress, hypoxia, death, transfusion
- Medical subject headings
- Malaria, Falciparum, Acidosis, Lactic, Dyspnea, Hypoxia, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cases: Severe inpatient malaria, survivors or decedents. Severe malaria consists of any one or combination of severe malarial anemia (SMA), cerebral malaria (CM), lactic acidosis (LA), or a respiratory distress syndrome with hypoxia. | |
| 2 | Controls: Controls consist of mildly-affected children with P falciparum malaria who are either managed as inpatients or outpatients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined severe morbidity & mortality
Measured: Discharge
Secondary outcomes (1)
Laboratory indices of potential cytoadhesion (lactate, cell counts)
Measured: Presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
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 Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Investigators
- Nicolette Nabukeera-Barungi, MBChB, MMEd, Study director, Mulago Hospital/Makerere University (lead local investigator)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707200
- Sponsor's protocol ID
- 07-0548-AE
- Other IDs
- HS 356, ISBT 777531237
- Acronym
- CPM
- Status last verified
- Jul 2009
- First submitted
- 26 Jun 2008
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Cserti CM, Dzik WH. The ABO blood group system and Plasmodium falciparum malaria. Blood. 2007 Oct 1;110(7):2250-8. doi: 10.1182/blood-2007-03-077602. Epub 2007 May 14.
PubMed 17502454Cserti-Gazdewich CM, Dzik WH, Dorn ME, Quagliaroli RO, Xu S, Ssewanyana I, Nayyar R, Preffer FI. Quantitation of CD36 (platelet glycoprotein IV) expression on platelets and monocytes by flow cytometry: application to the study of Plasmodium falciparum malaria. Cytometry B Clin Cytom. 2009 Mar;76(2):127-34. doi: 10.1002/cyto.b.20443.
PubMed 18671254Cserti-Gazdewich CM, Dhabangi A, Musoke C, Ssewanyana I, Ddungu H, Nakiboneka-Ssenabulya D, Nabukeera-Barungi N, Mpimbaza A, Dzik WH. Inter-relationships of cardinal features and outcomes of symptomatic pediatric Plasmodium falciparum MALARIA in 1,933 children in Kampala, Uganda. Am J Trop Med Hyg. 2013 Apr;88(4):747-756. doi: 10.4269/ajtmh.12-0668. Epub 2013 Jan 28.
PubMed 23358640
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors
- ClinicalTrials.gov ID
- NCT00707200
- Acronym / sponsor ID
- CPM / 07-0548-AE
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- severe malarial anemia (SMA), cerebral malarial (CM), lactic acidosis, hyperparasitemia, respiratory distress, hypoxia, death, transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 30 Jun 2008 (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.
The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children.
Detailed description
Every year, nearly 2 million children die from infection with Plasmodium falciparum malaria. When red blood cells (RBC) become infected with malaria, a sticky parasite-derived knob protein, termed PfEMP-1, erupts on the RBC surfaces. PfEMP-1 attaches to several blood group molecules, including those found on other RBC, on blood vessels, and on the cells that normally help to stop bleeding (platelets). The cellular sticking results in a dangerous interruption in blood flow to vital organs, causing brain injury (cerebral malaria), systemic shock (lactic acidosis), and death. Depending on an individual's inherited blood groups of relevance, adhesion may be extensive or limited. In the laboratory, PfEMP-1 adheres to RBCs via the A or B (but not the O) antigens of the ABO blood group system, and to platelets and blood vessels via platelet glycoprotein IV (CD36) and ICAM-1. Consistent with the expected evolutionary advantage of being deficient in these binding targets, blood type O and low-expression of CD36 are found more frequently among Africans. The "Cytoadherence in Pediatric Malaria" (CPM) project is determining the distribution of adhesive blood group molecules in a cohort of 2000 Ugandan children according to the extent of malaria severity and death, and thus their ultimate clinical and evolutionary significance in malarial survival. This knowledge may serve as the grounds for developing targeted cytoadhesion-interruption therapies in our fight against malaria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cases: Severe inpatient malaria, survivors or decedents. Severe malaria consists of any one or combination of severe malarial anemia (SMA), cerebral malaria (CM), lactic acidosis (LA), or a respiratory distress syndrome with hypoxia. |
| 2 | – | –Controls: Controls consist of mildly-affected children with P falciparum malaria who are either managed as inpatients or outpatients. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium falciparum parasitemia.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Plasmodium falciparum malaria infection
Key exclusion criteria (1 listed)
- HIV or significant malnutrition
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
Combined severe morbidity & mortality
Time frame: Discharge
1 secondary outcome
Laboratory indices of potential cytoadhesion (lactate, cell counts)
Time frame: Presentation
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 26 Jan 2010.
- Background: PubMed 17502454Cserti CM, Dzik WH. The ABO blood group system and Plasmodium falciparum malaria. Blood. 2007 Oct 1;110(7):2250-8. doi: 10.1182/blood-2007-03-077602. Epub 2007 May 14.
- Results publication: PubMed 18671254Cserti-Gazdewich CM, Dzik WH, Dorn ME, Quagliaroli RO, Xu S, Ssewanyana I, Nayyar R, Preffer FI. Quantitation of CD36 (platelet glycoprotein IV) expression on platelets and monocytes by flow cytometry: application to the study of Plasmodium falciparum malaria. Cytometry B Clin Cytom. 2009 Mar;76(2):127-34. doi: 10.1002/cyto.b.20443.
- Derived from this study: PubMed 23358640Cserti-Gazdewich CM, Dhabangi A, Musoke C, Ssewanyana I, Ddungu H, Nakiboneka-Ssenabulya D, Nabukeera-Barungi N, Mpimbaza A, Dzik WH. Inter-relationships of cardinal features and outcomes of symptomatic pediatric Plasmodium falciparum MALARIA in 1,933 children in Kampala, Uganda. Am J Trop Med Hyg. 2013 Apr;88(4):747-756. doi: 10.4269/ajtmh.12-0668. Epub 2013 Jan 28.
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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.
Nicolette Nabukeera-Barungi, MBChB, MMEd study director
Mulago Hospital/Makerere University (lead local investigator)
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 Plasmodium Falciparum Malaria, run by University Health Network, Toronto at 1 site in Uganda.
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 1 inclusion and 1 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 26 Jan 2010. 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 Uganda. 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?
Combined severe morbidity & mortality (time frame: Discharge). 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 NCT00707200, 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 26 Jan 2010.