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| Name | Class |
|---|---|
| Xidea Solutions Limited | UNKNOWN |
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The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMistâ„¢) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArTiMist (artemether sublingual spray) | Experimental |
| |
| Intravenous Quinine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinine | Drug | 20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose | 24 hours after first dose | |
| Time for Parasite Count to Fall by 90% PCT(90) | The time taken for the parasite count to fall 90% from baseline | 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
| Time for Parasite Count to Fall by 50% PCT(50) | The time taken for the parasite count to fall 50% from baseline | 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
| Measure | Description | Time Frame |
|---|---|---|
| Parasite Clearance Time | Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained | 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
| Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose |
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Inclusion Criteria:
The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
The patient is a child that weighs between 5 and 15 kg (kilogram)
The patient has falciparum malaria as evidenced by
The patient has either
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl Bendel, MBChB MBA Dip Pharm Med MFPM | Xidea Solutions Limited | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26303805 | Derived | Bendel D, Rulisa S, Ansah P, Sirima S. Efficacy of a novel sublingual spray formulation of artemether in African children with Plasmodium falciparum malaria. Antimicrob Agents Chemother. 2015 Nov;59(11):6930-8. doi: 10.1128/AAC.00243-15. Epub 2015 Aug 24. |
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Patients were recruited at a single study centre in Rwanda during December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | ArTiMist | Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours |
| FG001 | Intravenous Quinine | Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ArTiMist | Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours |
| BG001 | Intravenous Quinine | Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose | For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment. | Posted | Number | participants | 24 hours after first dose |
|
Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
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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 | ArTiMist | Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria reinfection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr D Bendel | Xidea Solutions Limited | daryl@xideasolutions.com |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D011803 | Quinine |
| D000077549 | Artemether |
| ID | Term |
|---|---|
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
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| Artemether | Drug | Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy |
|
|
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication |
| 24 hours after first dose |
| Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose | Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication | 12 h (hours) after first dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Parasite Clearance Time | Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained | Posted | Mean | Standard Deviation | Hours | 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
|
|
|
| Primary | Time for Parasite Count to Fall by 90% PCT(90) | The time taken for the parasite count to fall 90% from baseline | Posted | Mean | Standard Deviation | hours | 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
|
|
|
|
| Secondary | Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose | Reduction in parasitaemia from baseline at 24 h after the first dose of study medication | For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h | Posted | Median | Full Range | Percent reduction | 24 hours after first dose |
|
|
|
| Primary | Time for Parasite Count to Fall by 50% PCT(50) | The time taken for the parasite count to fall 50% from baseline | Posted | Mean | Standard Deviation | hours | 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h |
|
|
|
|
| Secondary | Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose | Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication | For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h | Posted | Median | Full Range | Percent reduction | 12 h (hours) after first dose |
|
|
|
| 0 |
| 16 |
| 13 |
| 16 |
| EG001 | Intravenous Quinine | Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly | 1 | 15 | 11 | 15 |
| Conjunctivitis | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoae | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bacterial Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Malaria reinfection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
The PI was restricted from publishing results for 6 months from the end of the trial. This has now passed and the PI is free to publish the results without restriction
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |