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| ID | Type | Description | Link |
|---|---|---|---|
| LSHTM Ethics 5197 | Other Identifier | London School of Hygiene and Tropical Medicine |
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| Name | Class |
|---|---|
| Uganda Malaria Surveillance Project | OTHER |
| Ministry of Health, Uganda | OTHER_GOV |
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This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.
The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Amodiaquine +sulfadoxine-pyrimethamine | Active Comparator | Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets |
|
| Dihydroartemisinin-piperaquine | Active Comparator | Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet) |
|
| Placebo | Placebo Comparator | Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) |
|
| Sulfadoxine-pyrimethamine alone | Active Comparator | sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulfadoxine-pyrimethamine | Drug | 25 mg/kg po once on day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Parasitaemia (Unadjusted by Genotyping) | Proportion of participants whose thick blood smears that are positive for asexual parasites | after 42 days of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment | Proportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping | after 42 days of follow-up |
| Risk of New Infection (Adjusted by Genotyping) in All Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah G Staedke, MD | London School of Hygiene and Tropical Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20976051 | Derived | Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dihydroartemisinin-piperaquine | Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet) dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) |
| FG001 | Combination of Amodiaquine +Sulfadoxine-pyrimethamine | Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 |
| FG002 | Placebo | Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2) |
| FG003 | Sulfadoxine-pyrimethamine Alone | sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination of Amodiaquine +Sulfadoxine-pyrimethamine | Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Risk of Parasitaemia (Unadjusted by Genotyping) | Proportion of participants whose thick blood smears that are positive for asexual parasites | Posted | Count of Participants | Participants | after 42 days of follow-up |
|
42 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dihydroartemisinin-piperaquine | Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet) dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nankabirwa Joaniter | Makerere University Kampala | +256772676429 | jnankabirwa@yahoo.co.uk |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D000655 | Amodiaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| amodiaquine + sulfadoxine-pyrimethamine | Drug | Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 |
|
|
| dihydroartemisinin-piperaquine | Drug | 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) |
|
|
| Placebo | Other | dosed as for amodiaquine (10mg/kg po daily on days 1, 2) |
|
|
Proportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping |
| after 42 days of follow-up |
| Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment | Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up | Over 42 days of follow-up |
| Mean Change in Haemoglobin | Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens | Between day 0 to day 42 |
| Risk of Serious Adverse Events | Any untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization | over 42 days of follow-up |
| Acceptability of IPT Regimens | Perceived willingness to take study medication as routine preventive treatment | on day 7 |
| Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment | Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up | after 42 days of follow-up |
| BG001 | Dihydroartemisinin-piperaquine | Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet) dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) |
| BG002 | Placebo | Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2) |
| BG003 | Sulfadoxine-pyrimethamine Alone | sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bed net use | Count of Participants | Participants |
|
| Mean hemoglobin | Mean | Standard Deviation | g/dL |
|
| OG002 | Placebo | Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2) |
| OG003 | Sulfadoxine-pyrimethamine Alone | sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0 |
|
|
| Secondary | Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment | Proportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping | Posted | Count of Participants | Participants | after 42 days of follow-up |
|
|
|
| Secondary | Risk of New Infection (Adjusted by Genotyping) in All Participants | Proportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping | Posted | Count of Participants | Participants | after 42 days of follow-up |
|
|
|
| Secondary | Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment | Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up | Posted | Count of Participants | Participants | Over 42 days of follow-up |
|
|
|
| Secondary | Mean Change in Haemoglobin | Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens | Posted | Mean | 95% Confidence Interval | g/dL | Between day 0 to day 42 |
|
|
|
| Secondary | Risk of Serious Adverse Events | Any untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization | Posted | Count of Participants | Participants | over 42 days of follow-up |
|
|
|
| Secondary | Acceptability of IPT Regimens | Perceived willingness to take study medication as routine preventive treatment | Posted | Count of Participants | Participants | on day 7 |
|
|
|
| Secondary | Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment | Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up | Risk of recrudescence in children with parasites on day 0 (n=392). The risk of recrudescence was estimated using Kaplan-Meier survival techniques with corresponding 95% confidence intervals (CI) calculated using Greenwood variance estimates. | Posted | Count of Participants | Participants | after 42 days of follow-up |
|
|
|
| 0 |
| 198 |
| 0 |
| 198 |
| 117 |
| 198 |
| EG001 | Combination of Amodiaquine +Sulfadoxine-pyrimethamine | Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 | 0 | 200 | 0 | 200 | 122 | 200 |
| EG002 | Placebo | Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2) | 0 | 196 | 0 | 196 | 124 | 196 |
| EG003 | Sulfadoxine-pyrimethamine Alone | sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0 | 0 | 186 | 0 | 186 | 114 | 186 |
| Headache | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |