Trial · NCT01258049
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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 |
| Secondary | Late Clinical Failure | 28 days after the start of treatment | * 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 |
| Secondary | Late Parasitological Failure | 28 days after the start of treatment | o Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature ≤ 38.0°C |
| Secondary | Time to Return to Full Consciousness | 28 days after start of treatment | 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. For the Blantyre Coma Scale Total - maximum 5, eye movement - maximum 1, best motor response - maximum 2, best verbal response - maximum 2 |
| Secondary | Time to Return to Normal Per os Status | 28 days after start of treatment | Time in hours to return to normal per os status. Normal per os was when the investigator considered the patient to be able to eat and drink normally. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities | 28 days after start of treatment | |
| Secondary | Number of Deaths or Neurological Sequelae at Day 28 | 28 days after start of treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01258049/registered