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Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
555 trials monitored
See 31 trials at risk
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to \<5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
Trial Details
NCT Number NCT07713602
Lead Sponsor Novartis Pharmaceuticals
Conditions Malaria
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov