Phase 3
N=151
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01258049 ↗Enrolled (actual)
151
Serious AEs
9.3%
Results posted
Feb 2014
Primary outcome: Primary: Parasitological Success (MITT) — 66; 28; 4; 43 participants — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Artemether Sublingual Spray (Drug); Quinine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Proto Pharma Ltd
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parasitological Success (MITT) |
66; 28; 4; 43 | <0.005 sig |
| PRIMARY Parasitological Success (PP) |
65; 28; 3; 41 | <0.005 sig |
| SECONDARY Parasite Clearance Time (PCT) [MITT Population] |
30.29; 68.30 | <0.05 sig |
| SECONDARY PCT 90 [MITT Population] |
15.02; 27.93 | <0.005 sig |
| SECONDARY PCT 50 [MITT Population] |
9.42; 18.58 | <0.005 sig |
| SECONDARY PRR 24 [MITT Population] |
98.2; 44.5 | <0.005 sig |
| SECONDARY PRR 12 [MITT Population] |
47.6; -132.2 | 0.06 |
| SECONDARY Fever Clearance Time (FCT) |
42.6; 41.6 | 0.86 |
| SECONDARY Complete Cure Rate |
41; 46; 14; 17 | 0.99 |
| SECONDARY Early Treatment Failure |
0; 14 | — |
| SECONDARY Late Clinical Failure |
3; 1 | — |
| SECONDARY Late Parasitological Failure |
12; 14 | — |
| SECONDARY Time to Return to Full Consciousness |
20.8; 23.0 | — |
| SECONDARY Time to Return to Normal Per os Status |
22.1; 25.3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities |
5; 6 | — |
| SECONDARY Number of Deaths or Neurological Sequelae at Day 28 |
0; 0 | — |
Summary
The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications
Eligibility Criteria
Inclusion Criteria
- The patient's legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial
- The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive
- The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P Falciparum per mcl)
- The patient has either:
- severe or complicated falciparum malaria as determined by the investigator based on the WHO criteria for severity, and/or
- uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.
Exclusion Criteria
- The patient's legally acceptable representative does not provide informed consent for participation, or the child if capable, does not assent to participation in the trial.
- Ability to tolerate oral therapy
- Patient has received any antimalarial therapy within the 7 days prior to first study drug administration.
- Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
- Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .
Data sourced from ClinicalTrials.gov (NCT01258049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.