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Cohort Event Monitoring Study of Pyramax®

NCT03201770 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8572

Last updated 2019-06-26

No results posted yet for this study

Summary

The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (\<1 year of age).

Conditions

  • Malaria,Falciparum

Interventions

DRUG

pyronaridine artesunate

Antimalarial treatment

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Ramharter, MD, DTM&H · CERMEL, University of Tübingen, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-04-10
Completion
2019-04-10

Countries

  • Cameroon
  • Côte d’Ivoire
  • Democratic Republic of the Congo
  • Gabon
  • Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201770 on ClinicalTrials.gov