MalariaNCT04858087
Malawi International Center of Excellence in Malaria Research School-based Cohort
An observational study of Malaria and Malaria,Falciparum, run by University of Maryland, Baltimore.
Trial summary
A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum, Anemia
- What is being tested?
- Screening and treatment
- How many people
- 786 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2015to 13 Nov 2015
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 15 students per grade (1 through 8) were randomly sampled in four primary schools
Who may be able to join
- Randomly selected student at a participating school
Who cannot join
- Parent or guardian not available for consent
- Age <5 or >= 16 years
- Known allergy or adverse reaction to lumefantrine-artemether
- Child will not attend this school during the time of the survey
- For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)
About this study
Official title: Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)
A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.
Read the detailed description
Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.
- Conditions
- Malaria, Malaria,Falciparum, Anemia
- Being tested
- Screening and treatment
- Keywords
- cohort, screen and treat, artemether-lumefantrine
- Medical subject headings
- Malaria, Malaria, Falciparum, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and treatmentOther
Also called mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine
Students were screened by mRDTs and treated with artemether-lumefantrine if positive
| Study group | Role | What they receive |
|---|---|---|
| All students | All participating students were screened for Pf infection using malaria rapid diagnostic tests (mRDTs) and treated if positive. All were followed 1, 2, and 6 weeks after screening-and-treatment. Receives: Other: Screening and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
P. falciparum infection
Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
Measured: 6 weeks after screening
P. falciparum gametocyte presence
Pfs25 quantitative reverse transcriptase PCR
Measured: 6 weeks after screening
P. falciparum gametocyte density
Pfs25 quantitative reverse transcriptase PCR
Measured: 6 weeks after screening
Secondary outcomes (2)
Microscopic P. falciparum infection
Pf infection detected by microscopy
Measured: 6 weeks after screening
Anemia
Hb measured by Hemocue and categorized using WHO age and gender specific values
Measured: 6 weeks after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start24 Mar 2015
- Primary completion13 Nov 2015
- Study completion13 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Michigan State University, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Miriam Laufer, University of Maryland, Baltimore
- Investigators
- Miriam Laufer, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858087
- Sponsor's protocol ID
- HP-00052129
- Other IDs
- U19AI089683
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available via a publicly available database, such as ClinEpiDB
Publications
Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.
PubMed 33767384Cohee LM, Peterson I, Buchwald AG, Coalson JE, Valim C, Chilombe M, Ngwira A, Bauleni A, Schaffer-DeRoo S, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-Based Malaria Screening and Treatment Reduces Plasmodium falciparum Infection and Anemia Prevalence in Two Transmission Settings in Malawi. J Infect Dis. 2022 Aug 12;226(1):138-146. doi: 10.1093/infdis/jiac097.
PubMed 35290461
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)
- ClinicalTrials.gov ID
- NCT04858087
- Acronym / sponsor ID
- HP-00052129
- Conditions
- Malaria, Malaria,Falciparum, Anemia
- Keywords
- cohort, screen and treat, artemether-lumefantrine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Michigan State University, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- 13 Nov 2015 (actual)
- Study completion
- 13 Nov 2015 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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.
A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.
Detailed description
Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All students | – | Other: Screening and treatmentAll participating students were screened for Pf infection using malaria rapid diagnostic tests (mRDTs) and treated if positive. All were followed 1, 2, and 6 weeks after screening-and-treatment. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 15 students per grade (1 through 8) were randomly sampled in four primary schools
Key inclusion criteria (1 listed)
- Randomly selected student at a participating school
Key exclusion criteria (5 listed)
- Parent or guardian not available for consent
- Age <5 or >= 16 years
- Known allergy or adverse reaction to lumefantrine-artemether
- Child will not attend this school during the time of the survey
- For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)
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 |
|---|---|---|
| Screening and treatmentAlso: mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrineStudents were screened by mRDTs and treated with artemether-lumefantrine if positive | Other | All students |
Primary outcome
P. falciparum infection
Time frame: 6 weeks after screening
Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
P. falciparum gametocyte presence
Time frame: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
P. falciparum gametocyte density
Time frame: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
2 secondary outcomes
Microscopic P. falciparum infection
Time frame: 6 weeks after screening
Anemia
Time frame: 6 weeks after screening
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 Apr 2021.
- Results publication: PubMed 33767384Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.
- Derived from this study: PubMed 35290461Cohee LM, Peterson I, Buchwald AG, Coalson JE, Valim C, Chilombe M, Ngwira A, Bauleni A, Schaffer-DeRoo S, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-Based Malaria Screening and Treatment Reduces Plasmodium falciparum Infection and Anemia Prevalence in Two Transmission Settings in Malawi. J Infect Dis. 2022 Aug 12;226(1):138-146. doi: 10.1093/infdis/jiac097.
- Individual participant dataSharing planned: Yes. data will be available via a publicly available database, such as ClinEpiDB
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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.
Miriam Laufer, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Malaria,Falciparum, run by University of Maryland, Baltimore.
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 5 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 Apr 2021. 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 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?
P. falciparum infection (time frame: 6 weeks after screening). The study lists 3 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 NCT04858087, which also lists 2 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 Apr 2021.