From your site, below are the PhaseIII trial parameters. What to look for in the published data (due in Q4) is whether 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"
Whilst many drugs fail PhaseIII trials the artemether drug is not on trial here it is the drug delivery technology. If the trial shows that the delivery technology is better than IV quinine, then one would expect another SP run in Q4.
Primary Outcome Measures: Parasitological success [Time Frame: 24 hours after start of treatment] [Designated as safety issue: No] Parasitological success defined as a reduction in parasite count of = 90% of baseline at 24 hours after the first dose
Secondary Outcome Measures: Complete cure (crude and PCR (polymerase chain reaction) adjusted) [Time Frame: 28 days after the start of treatment] [Designated as safety issue: No] 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
Parasite clearance [Time Frame: 28 days after start of treatment] [Designated as safety issue: No] 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. Parasite reduction ratio at 12 hours (PRR12) and 24 hours (PRR24) after first dose. Time for parasite count to fall by 50% (PCT50) and 90% (PCT90)
Fever clearance time (FCT) [Time Frame: 28 days after start of treatment] [Designated as safety issue: No] Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature < 38.0) for at least 24 hours.
Early treatment failure [Time Frame: Three days after the start of treatment] [Designated as safety issue: No] 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
Late clinical failure [Time Frame: 28 days after the start of treatment] [Designated as safety issue: No ] Signs of severe malaria on any day between Day 4 and Day 28 in the presence of parasitaemia, without previously meeting any of the criteria of early treatment failure Presence of parasitaemia and tympanic temperature = 38.0°C (or history of fever), on any day between Day 4 and Day 28, without previously meeting any of the criteria of early treatment failure
Late parasitological failure [Time Frame: 28 days after the start of treatment] [Designated as safety issue: No] Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature = 38.0°C
Time to return to normal clinical status [Time Frame: 28 days after start of treatment] [Designated as safety issue: No ] Time in hours to return to normal per os status Time in hours to return to full consciousness (Blantyre Coma Scale = 5), if level of consciousness is reduced (Blantyre Coma Scale <5) prior to dosing or within 24hours of first dosing
Number and incidence of treatment emergent adverse events and serious adverse events, of possible, probably and definite causalities [Time Frame: 28 days after start of treatment] [Designated as safety issue: Yes]
Number of deaths or neurological sequelae at Day 28 [Time Frame: 28 days after start of treatment] [Designated as safety issue: Yes]
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