Phase 2
N=31
Efficacy of ArTiMist™ in Children
Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01047436 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Jan 2011
Primary outcome: Primary: Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose — 14; 10 participants — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quinine (Drug); Artemether (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Proto Pharma Ltd
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose |
14; 10 | 0.17 |
| PRIMARY Time for Parasite Count to Fall by 90% PCT(90) |
17.6; 19.8 | 0.70 |
| PRIMARY Time for Parasite Count to Fall by 50% PCT(50) |
12.0; 10.8 | 0.76 |
| SECONDARY Parasite Clearance Time |
35.7; 51.2 | — |
| SECONDARY Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose |
100.0; 96.9 | — |
| SECONDARY Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose |
79.6; 75.9 | — |
Summary
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.
Eligibility Criteria
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
- Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided >500 P Falciparum /mcl) and /or
- Positive RDT (rapid diagnostic test)for malaria
- The patient has either
- severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
- the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.
Exclusion Criteria
- Attending relative or parent 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 treatment with an artemisinin or quinine in the last 24 hours
- Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
- Patient is allergic or intolerant to artemisinins.
Data sourced from ClinicalTrials.gov (NCT01047436). 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.