Cohort Event Monitoring Study of Pyramax®

NCT03201770 | Completed Phase 4 DMC

• 1 other identifier: SP-C-021-15
• Study Type: interventional
• Target: 8,572
• Locations: 5 countries
• Sites: 5

Brief 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

Keywords

Uncomplicated Malaria; Pyramax; Pyronaridine artesunate

Outcome Measures

Primary Outcomes (1)

• Evaluation and identification of hepatic safety events, including raised liver function tests

  Evaluation and identification of hepatic safety events (including raised liver function tests - LFTs) of Pyramax in a sub group of malaria patients enrolled with LFTs \>2xUL.

  Assessment up to Day 28.

Secondary Outcomes (2)

• Overall safety

  Assessment up to Day 28.

• Evaluation of Efficacy

  Assessment up to Day 28.

Study Arms (1)

Pyramax

EXPERIMENTAL

Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)

Drug: pyronaridine artesunate

Interventions

pyronaridine artesunate DRUG

Antimalarial treatment

Also known as: Pyramax

Pyramax

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead
• Medicines for Malaria Venture: collaborator

Study Sites (5)

The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa

Yaoundé, Cameroon

Location

Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)

Bouaké, BP 1500, Côte d’Ivoire

Location

Centre de Recherche du Centre Hospitalier du Mont Amba

Kinshasa, XI, Democratic Republic of the Congo

Location

CERMEL, Albert Schweitzer Hospital

Lambaréné, BP 118, Gabon

Location

Centre de Santé FCRM, Hospital of Talangai

Brazzaville, Republic of the Congo

Location

Related Publications (3)

• Ramharter M, Djimde AA, Borghini-Fuhrer I, Miller R, Shin J, Aspinall A, Richardson N, Wibberg M, Fleckenstein L, Arbe-Barnes S, Duparc S. Safety and efficacy of pyronaridine-artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study. Malar J. 2024 Feb 28;23(1):61. doi: 10.1186/s12936-024-04885-3.

  PMID: 38418982 DERIVED

• Koehne E, Zander N, Rodi M, Held J, Hoffmann W, Zoleko-Manego R, Ramharter M, Mombo-Ngoma G, Kremsner PG, Kreidenweiss A. Evidence for in vitro and in vivo activity of the antimalarial pyronaridine against Schistosoma. PLoS Negl Trop Dis. 2021 Jun 24;15(6):e0009511. doi: 10.1371/journal.pntd.0009511. eCollection 2021 Jun.

  PMID: 34166393 DERIVED

• Tona Lutete G, Mombo-Ngoma G, Assi SB, Bigoga JD, Koukouikila-Koussounda F, Ntamabyaliro NY, Ntoumi F, Agnandji ST, Groger M, Shin J, Borghini-Fuhrer I, Arbe-Barnes S, Allen SJ, Kremsner PG, Miller R, Duparc S, Ramharter M; CANTAM study group. Pyronaridine-artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study. PLoS Med. 2021 Jun 15;18(6):e1003669. doi: 10.1371/journal.pmed.1003669. eCollection 2021 Jun.

  PMID: 34129601 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

pyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Michael Ramharter, MD, DTM&H

  CERMEL, University of Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 28, 2017
• Study Start: June 22, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: June 26, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CA (1); GA (1); CÔ (1); RE (1)