MalariaPhase 3SBMCNCT01231880
School Based Malaria Control in Ugandan Schoolchildren
A Phase 3 study testing Four monthly IPT with dihydroartemisinin Piperaquine (DP) and Monthly IPT using DP in people with Malaria, run by Makerere University at 1 site in Uganda.
Trial summary
The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Four monthly IPT with dihydroartemisinin Piperaquine (DP) and Monthly IPT using DP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 740 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 3
- 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 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 6 - 14 years
- Pupils enrolled at participating school
- Willingness of the parent/guardian to provide consent
- Provision of assent by pupil (those above 8 years)
Who cannot join
- Known allergy or history of adverse reaction to study medications
- Intention of changing of schools during the follow-up period
- History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.
- Conditions
- Malaria
- Being tested
- Four monthly IPT with dihydroartemisinin Piperaquine (DP), Monthly IPT using DP, Placebo given every month
- Keywords
- Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four monthly IPT with dihydroartemisinin Piperaquine (DP)Drug
Also called Duocortexin
Given every 4 months (once a school term)
Monthly IPT using DPDrug
Also called Duocortexin
Given every month
Placebo given every monthDrug
Also called Placebo
No active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Four monthly IPT | Experimental | IPT give once a school term (every four months) Receives: Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP) |
| Monthly IPT | Experimental | IPT given every month Receives: Drug: Monthly IPT using DP |
| Placebo | Placebo comparator | No active drug in the placebo Receives: Drug: Placebo given every month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Clinical Malaria
Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.
Measured: 1 year
Cognitive function tests
Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)
Measured: 1 year
Secondary outcomes (5)
Risk of parasitemia
presence of asexual parasites on blood smear
Measured: 1 year
Risk of hospital admissions
Admission of any cause
Measured: 1 year
Risk of adverse events
Any untoward medical occurrence in a participant taking study medication
Measured: 1 year
School performance
Average position in class as reported in the end of the year school report
Measured: 1 year
Prevalence of anemia
Proportion of hemoglobin measurements < 10 g/dL.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Faculty of Medicine, Makerere University
- Investigators
- Joaniter I Nankabirwa, MSc CEB, Principal investigator, Makerere University Kampala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231880
- Sponsor's protocol ID
- MCDC-SBMC
- Acronym
- SBMC
- Status last verified
- May 2013
- First submitted
- 29 Oct 2010
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nankabirwa JI, Conrad MD, Legac J, Tukwasibwe S, Tumwebaze P, Wandera B, Brooker SJ, Staedke SG, Kamya MR, Nsobya SL, Dorsey G, Rosenthal PJ. Intermittent Preventive Treatment with Dihydroartemisinin-Piperaquine in Ugandan Schoolchildren Selects for Plasmodium falciparum Transporter Polymorphisms That Modify Drug Sensitivity. Antimicrob Agents Chemother. 2016 Sep 23;60(10):5649-54. doi: 10.1128/AAC.00920-16. Print 2016 Oct.
PubMed 27401569Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
PubMed 24621953
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
- ClinicalTrials.gov ID
- NCT01231880
- Acronym / sponsor ID
- SBMC / MCDC-SBMC
- Conditions
- Malaria
- Keywords
- Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Nov 2010 (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 investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Four monthly IPT | Experimental | Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)IPT give once a school term (every four months) |
| Monthly IPT | Experimental | Drug: Monthly IPT using DPIPT given every month |
| Placebo | Placebo comparator | Drug: Placebo given every monthNo active drug in the placebo |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≥ 6 - 14 years
- Pupils enrolled at participating school
- Willingness of the parent/guardian to provide consent
- Provision of assent by pupil (those above 8 years)
Key exclusion criteria (3 listed)
- Known allergy or history of adverse reaction to study medications
- Intention of changing of schools during the follow-up period
- History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care
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 |
|---|---|---|
| Four monthly IPT with dihydroartemisinin Piperaquine (DP)Also: DuocortexinGiven every 4 months (once a school term) | Drug | Four monthly IPT |
| Monthly IPT using DPAlso: DuocortexinGiven every month | Drug | Monthly IPT |
| Placebo given every monthAlso: PlaceboNo active ingredient | Drug | Placebo |
Primary outcome
Risk of Clinical Malaria
Time frame: 1 year
Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.
Cognitive function tests
Time frame: 1 year
Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)
5 secondary outcomes
Risk of parasitemia
Time frame: 1 year
Risk of hospital admissions
Time frame: 1 year
Risk of adverse events
Time frame: 1 year
School performance
Time frame: 1 year
Prevalence of anemia
Time frame: 1 year
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 23 May 2013.
- Derived from this study: PubMed 27401569Nankabirwa JI, Conrad MD, Legac J, Tukwasibwe S, Tumwebaze P, Wandera B, Brooker SJ, Staedke SG, Kamya MR, Nsobya SL, Dorsey G, Rosenthal PJ. Intermittent Preventive Treatment with Dihydroartemisinin-Piperaquine in Ugandan Schoolchildren Selects for Plasmodium falciparum Transporter Polymorphisms That Modify Drug Sensitivity. Antimicrob Agents Chemother. 2016 Sep 23;60(10):5649-54. doi: 10.1128/AAC.00920-16. Print 2016 Oct.
- Derived from this study: PubMed 24621953Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
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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.
Joaniter I Nankabirwa, MSc CEB principal investigator
Makerere University Kampala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Four monthly IPT with dihydroartemisinin Piperaquine (DP) and Monthly IPT using DP in people with Malaria, run by Makerere University 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 4 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 23 May 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Risk of Clinical Malaria (time frame: 1 year). The study lists 2 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 NCT01231880, 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 23 May 2013.