Trial · NCT01258049

Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

NCT01258049, Phase 3, Completed, Proto Pharma Ltd; results first posted 2014-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Superiority of ArTiMist Versus Quinine in Children With Severe Malaria. Trials, record NCT01258049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01258049

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
NCT number: NCT01258049
Status: Completed
Phases: Phase 3
Enrollment: 151 participants, actual
Lead sponsor: Proto Pharma Ltd
Conditions: Plasmodium Falciparum Malaria
Interventions: Artemether Sublingual Spray, Quinine
First posted: 2010-12-10
Last updated: 2014-02-28
Results first posted: 2014-02-28

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Parasitological Success (MITT)	24 hours after start of treatment	Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose
Primary	Parasitological Success (PP)	24 hours after start of treatment	Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose
Secondary	Parasite Clearance Time (PCT) [MITT Population]	28 days after start of treatment	Parasite clearance time (PCT). Time in hours from the initiation of therapy until the first of two successive parasite negative smears (zero parasite counts) are obtained
Secondary	PCT 90 [MITT Population]	28 days after start of treatment	Time for parasite counts to fall by 90%
Secondary	PCT 50 [MITT Population]	28 days after start of treatment	Time for parasite counts to fall by 50%
Secondary	PRR 24 [MITT Population]	28 days after start of treatment	The percentage reduction in parasite counts 24 hours after first dose
Secondary	PRR 12 [MITT Population]	28 days after start of treatment	The percentage reduction in parasite counts 12 hours after first dose
Secondary	Fever Clearance Time (FCT)	28 days after start of treatment	Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature \< 38.0) that lasted at least 24 hours.
Secondary	Complete Cure Rate	28 days after the start of treatment	The complete resolution of clinical signs and symptoms, malaria-related laboratory abnormalities, and elimination of asexual parasites by Day 7, with no recurrence up to Day 28 (+/- 2 days), and the 48h parasite count to be \< 25% of baseline with no clinical deterioration
Secondary	Early Treatment Failure	Three days after the start of treatment	Early treatment failure is indicated by one or more of the following: * Parasite count on Day 2 \> Day 0, irrespective of temperature * Parasite count on Day 3 \> 0 with tympanic temperature ≥ 38.0°C * Parasite count on Day 3 ≥ 25% of baseline * Administration of rescue antimalarial treatment

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Parasitological Success (MITT)	24 hours after start of treatment	The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.~7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count	participants	NUMBER
SECONDARY	Parasite Clearance Time (PCT) [MITT Population]	28 days after start of treatment		hours	MEAN
SECONDARY	PCT 90 [MITT Population]	28 days after start of treatment		hours	MEAN
SECONDARY	PCT 50 [MITT Population]	28 days after start of treatment		hours	MEAN
SECONDARY	PRR 24 [MITT Population]	28 days after start of treatment		percentage of baseline	MEAN
SECONDARY	PRR 12 [MITT Population]	28 days after start of treatment		percentage of baseline	MEAN
SECONDARY	Fever Clearance Time (FCT)	28 days after start of treatment		hours	MEAN
SECONDARY	Complete Cure Rate	28 days after the start of treatment	For some subjects, this endpoint was not evaluable and/or not all data was received.	participants	NUMBER
SECONDARY	Early Treatment Failure	Three days after the start of treatment		participants	NUMBER
SECONDARY	Late Clinical Failure	28 days after the start of treatment		participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Parasitological Success (MITT)	ArTiMist	Success	66		participants
Parasitological Success (MITT)	Quinine	Success	28		participants
Parasitological Success (MITT)	ArTiMist	Not Success	4		participants
Parasitological Success (MITT)	Quinine	Not Success	43		participants
Parasite Clearance Time (PCT) [MITT Population]	ArTiMist		30.29	Standard Deviation 13.21	hours
Parasite Clearance Time (PCT) [MITT Population]	Quinine		68.30	Standard Deviation 98.04	hours
PCT 90 [MITT Population]	ArTiMist		15.02	Standard Deviation 5.82	hours
PCT 90 [MITT Population]	Quinine		27.93	Standard Deviation 18.03	hours
PCT 50 [MITT Population]	ArTiMist		9.42	Standard Deviation 5.72	hours
PCT 50 [MITT Population]	Quinine		18.58	Standard Deviation 9.19	hours

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ArTiMist	77
Overall Study	STARTED	Quinine	74
Overall Study	COMPLETED	ArTiMist	75
Overall Study	COMPLETED	Quinine	72
Overall Study	NOT COMPLETED	ArTiMist	2
Overall Study	NOT COMPLETED	Quinine	2

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	ArTiMist	6	77	6
other	Anaemia	Blood and lymphatic system disorders	Quinine	12	74	12
other	Abdominal pain	Gastrointestinal disorders	ArTiMist	0	77	0
other	Abdominal pain	Gastrointestinal disorders	Quinine	4	74	4
other	Vomiting	Gastrointestinal disorders	ArTiMist	5	77	5
other	Vomiting	Gastrointestinal disorders	Quinine	2	74	2
other	Pyrexia	General disorders	ArTiMist	7	77	7
other	Pyrexia	General disorders	Quinine	6	74	6
other	Malaria	Infections and infestations	ArTiMist	17	77	17
other	Malaria	Infections and infestations	Quinine	14	74	14

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ArTiMist
Total, all-cause mortality	Quinine
Total, other adverse events	ArTiMist	43	77
Total, other adverse events	Quinine	44	74
Total, serious adverse events	ArTiMist	4	77
Total, serious adverse events	Quinine	10	74

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26303805	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ArTiMist vs Quinine: Late Parasitological Failure	Trial comparisons
ArTiMist vs Quinine: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities	Trial comparisons
ArTiMist vs Quinine: Number of Deaths or Neurological Sequelae at Day 28	Trial comparisons
ArTiMist vs Quinine: Late Clinical Failure	Trial comparisons
ArTiMist vs Quinine: Early Treatment Failure	Trial comparisons
ArTiMist vs Quinine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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