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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.
The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.
Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloroquine primaquine 14days | Other | P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines |
|
| artemether-lumefantrine primaquine 1day | Other | P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines |
|
| artemether-lumefantrine primaquine 14days | Other | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chloroquine | Drug | standard dose |
| |
| Artemether-lumefantrine combination |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28 | during follow up (day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | day 28 | |
| Fractional Change in Hb Between Baseline and Day 9 and 16 | day 0 and 16 | |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28806961 | Derived | Alam MS, Ley B, Nima MK, Johora FT, Hossain ME, Thriemer K, Auburn S, Marfurt J, Price RN, Khan WA. Molecular analysis demonstrates high prevalence of chloroquine resistance but no evidence of artemisinin resistance in Plasmodium falciparum in the Chittagong Hill Tracts of Bangladesh. Malar J. 2017 Aug 15;16(1):335. doi: 10.1186/s12936-017-1995-5. | |
| 27128675 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroquine Primaquine 14days | P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines chloroquine: standard dose Primaquine: 14 days |
| FG001 | Artemether-lumefantrine Primaquine 1day | P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: single dose |
| FG002 | Artemether-lumefantrine Primaquine 14days | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroquine Primaquine 14days | P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines chloroquine: standard dose Primaquine: 14 days |
| BG001 | Artemether-lumefantrine Primaquine 1day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28 | Posted | Number | events | during follow up (day 28) |
|
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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 | Chloroquine Primaquine 14days | P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines chloroquine: standard dose Primaquine: 14 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benedikt Ley | Menzies School of Health Research | 889468643 | benedikt.ley@menzies.edu.au |
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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 |
|---|---|
| D002738 | Chloroquine |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| D011319 | Primaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
standard dose |
|
| Primaquine | Drug | single dose |
|
| Primaquine | Drug | 14 days |
|
| Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 |
| on day 2 |
| Proportion of Patients With Any Parasitemia on Day 3 After Treatment | day 3 |
| Proportion of Patients With Fever on Day 2 After Treatment | day 2 |
| Recurrence of Parasitaemia Within 16 Days of Follow up | day 16 |
| Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count | day 16 |
| The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients | day 0 |
| Frequency and Type of Variants of the G6PD Gene Within the Study Population | Frequency and type of variants of the G6PD gene within the study population | day 0 or 1 |
| Ley B, Alam MS, Thriemer K, Hossain MS, Kibria MG, Auburn S, Poirot E, Price RN, Khan WA. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study. PLoS One. 2016 Apr 29;11(4):e0154015. doi: 10.1371/journal.pone.0154015. eCollection 2016. |
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
| BG002 | Artemether-lumefantrine Primaquine 14days | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: 14 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Artemether-lumefantrine Primaquine 14days | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: 14 days |
|
|
| Secondary | Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | Posted | Number | participants | day 28 |
|
|
|
| Secondary | Fractional Change in Hb Between Baseline and Day 9 and 16 | Posted | Mean | 95% Confidence Interval | percent change Hb | day 0 and 16 |
|
|
|
| Secondary | Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 | Posted | Number | participants with Hb under 8g/dl | on day 2 |
|
|
|
| Secondary | Proportion of Patients With Any Parasitemia on Day 3 After Treatment | Posted | Number | participants | day 3 |
|
|
|
| Secondary | Proportion of Patients With Fever on Day 2 After Treatment | Posted | Count of Participants | Participants | day 2 |
|
|
|
| Secondary | Recurrence of Parasitaemia Within 16 Days of Follow up | Posted | Number | Recurrences of Parsitaemia | day 16 |
|
|
|
| Secondary | Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count | Posted | Count of Participants | Participants | day 16 |
|
|
|
| Secondary | The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients | Posted | Median | Inter-Quartile Range | U/gHb | day 0 |
|
|
|
| Secondary | Frequency and Type of Variants of the G6PD Gene Within the Study Population | Frequency and type of variants of the G6PD gene within the study population | data were not collected | Posted | day 0 or 1 |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Artemether-lumefantrine Primaquine 1day | P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: single dose | 0 | 115 | 0 | 115 |
| EG002 | Artemether-lumefantrine Primaquine 14days | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines Artemether-lumefantrine combination: standard dose Primaquine: 14 days | 0 | 11 | 0 | 11 |
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| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
|