EDCTP longitudinal study

• Register: PACTR
• Last refreshed on: 27 May 2013
• Main ID: PACTR201105000286876
• Date of registration: 31/03/2011
• Primary sponsor: University of Bamako
• Public title: EDCTP longitudinal study
• Scientific title: A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of
• Date of first enrolment: 2011-06-01
• Target sample size: 4032
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201105000286876
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Block-randomization will be done to allocate the patients to the three treatment arms for each site within the country using computer software program,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Sodiomon B. Sirima
• Affiliation: Clinical trial project leader

• Name: Aissata Diallo
• Affiliation: Administrative Coordinator

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female patients from 2 years of age (6 months and above after the DSMB review (first 40 Pyramax patients have been re-treated at least once).
2. Body weight greater than or equal to 15 kg (5 kg and above after the DSMB review and when Pyronaridine- artesunate granule become available) with no clinical evidence of severe malnutrition.
3. Presence of acute uncomplicated Plasmodium sp. malaria by:
a. Fever, as defined by axillary temperature ? 37.5?C or oral/rectal/tympanic temperature ? 38?C, or history of fever in the previous 24 hours (not needed at reinclusion) and,
b. Positive microscopy of Plasmodium sp. with parasite density less than 200,000 parasites/?l
4. Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
5. Ability to swallow oral medication.
6. No documented malaria treatment for at least 2 weeks since last treatment for malaria (4 weeks for re-inclusion)
7. Ability and willingness to participate based on information given to parent or guardian and access to health facility. The patient is to comply with all scheduled follow-up visits.

Exclusion criteria: 1. Signs and symptoms of severe/complicated malaria.
2. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day.
3. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than 450 milliseconds[Note that a QTc ? 450 msec with either Bazett or Fridericia correction will be acceptable]), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological, endocrine, infectious, malignancy, psychiatric, generalised anxiety, psychosis, schizophrenia or other major psychiatric disorders), history of convulsions or other abnormality (including recent head trauma).
4. Anaemia, as defined by Hb ` 7 g/dL.
5. Febrile conditions caused by diseases other than malaria at the first inclusion and if oral treatment is not possible for the subsequent episode.
6. Hypersensitivity or allergic to study drug
7. Use of any other antimalarial agent, including traditional medicines known to have antimalarial properties, within 2 weeks prior to start of the study.
8. Female patients of child-bearing potential (b12 year old) must be neither pregnant (as demonstrated by a negative pregnancy test) nor planning to become pregnant nor lactating, during each 42 day period after treatment
9. Received an investigational drug within the past 4 weeks.
10. Known or suspected chronic alcohol abuse
11. Known active Hepatitis A, Hepatitis B or Hepatitis C.
12. Known positive for HIV antibody.
13. Liver function tests [ALT levels] more than 2 times upper limit of normal.
14. Known significant renal impairment as indicated by serum creatinine of more than 1.5 x ULN.


Age minimum: 0 Year
Age maximum: 100 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

The incidence rate of malaria and repeated treatment safety over 2 years

Secondary Outcome(s)

Efficacy

Secondary ID(s)

IP_07_ 31060_002

SP-C-013-11

Source(s) of Monetary Support

MMV

EDCTP