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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03201770 |
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Date of registration:
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21/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cohort Event Monitoring Study of Pyramax®
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Scientific title:
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Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax® |
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Date of first enrolment:
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June 22, 2017 |
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Target sample size:
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8572 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03201770 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Cameroon
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Congo
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Congo, The Democratic Republic of the
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Côte D'Ivoire
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Gabon
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Contacts
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Name:
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Michael Ramharter, MD, DTM&H |
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Address:
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Telephone:
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Email:
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Affiliation:
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CERMEL, University of Tübingen, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies
and in line with WHO recommendations:
- Fever or history of fever in the previous 24 h and/or the presence of anaemia,
for which pallor of the palms appears to be the most reliable sign in young
children.
- Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick
blood smear). analysis).
- Weight =5 kg - < 20 kg (granules); =20 kg (tablets).
- Ability to take an oral medication.
- Ability and willingness to participate based on signed informed consent (a parent or a
guardian has to sign for children below 18 years old) and on signed assent form for
minors that could be required per national regulations in each participating country.
- The patient has to comply with all scheduled follow-up visits.
Exclusion Criteria:
- Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal
pain associated with jaundice) or known severe liver disease (i.e. decompensated
cirrhosis, Child-Pugh stage 3 or 4).
- Known allergy to artemisinin and/or to pyronaridine.
- Known pregnancy.
- Lactating women should be excluded if other anti-malarial treatments are available.
- Complicated malaria as per WHO definition (Annex 2)
- Patients that the investigator considers would be at particular risk if receiving an
anti-malarial or if participating in the study.
- Patients having been treated with Pyramax in the previous 28 days.
Age minimum:
3 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria,Falciparum
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Intervention(s)
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Drug: pyronaridine artesunate
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Primary Outcome(s)
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Evaluation and identification of hepatic safety events, including raised liver function tests
[Time Frame: Assessment up to Day 28.]
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Secondary Outcome(s)
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Overall safety
[Time Frame: Assessment up to Day 28.]
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Evaluation of Efficacy
[Time Frame: Assessment up to Day 28.]
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Secondary ID(s)
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SP-C-021-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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