In malaria trials, it may be important to collect information regarding antimalarials taken in a protocol-defined period preceding the study and other concomitant/recent non-study medication. The protocol-defined period may be based on the elimination half-life of antimalarials that are locally available. Use of antibiotics with known antimalarial activity (as defined per protocol), or potentially interacting prior and concomitant medicines may be exclusion criteria for uncomplicated malaria clinical trials. Paracetamol is frequently used as an antipyretic; ibuprofen has also been used but is less common. Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs), other than paracetamol, and sometimes ibuprofen, are often prohibited during a study, as they may increase the risk of renal failure. Given the prevalence of co-morbidities such as HIV, tuberculosis, and bacterial infections in malaria endemic areas, antimicrobials (antiretroviral, antituberculosis, and antibiotic medicines) are common concomitant medications among malaria-infected subjects in later phase (or post-licensing) clinical trials. Data on any use of concomitant medicines (including antipyretics such as paracetamol, as well as traditional, alternative and complementary medicines) should be represented in the Concomitant Medications (CM) domain. Examples of this modeling can be found in the CDISC SDTMIG.

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