Ethiopian study shows potential of rapid diagnostic test for meningitis
Ethiopian researchers report that the introduction of a rapid molecular diagnostic test at a teaching hospital resulted in the first diagnosis of viral meningitis in routine clinical practice in Ethiopia. The study was published yesterday in BMC Infectious Diseases.
In the single-center study, cerebrospinal fluid (CSF) samples from patients with suspected meningitis at Jimma University Specialized Hospital were analyzed using a multiplex, polymerase chain reaction (PCR)-based system and conventional microbiologic methods. The aim of the study was to investigate which infectious agents were responsible for meningitis in a region of Ethiopia where treatment decisions are usually based on clinical findings alone and bacterial meningitis is frequently diagnosed, resulting in antibiotic overuse
Of the 218 CSF samples collected, microorganisms were detected by PCR in 21 (10%). The rates were 4% in neonates, 14% in pediatric patients, and 18% in adults. By comparison, conventional testing detected a microorganism in only five patients.
Virus was detected in 57% of the PCR-positive samples, bacteria in 33%, and fungi in 10%. The vast majority (90%) of patients, however, still received more than one antibiotic for the treatment of the meningitis episode, and there was no difference in the mean number of different antibiotics received or in the cumulative number of days with antibiotic treatment between patients with a microorganism detected in CSF and those without. The authors of the study suggest this could be caused by a lack of clinical treatment guidelines or poor communication of test results to clinicians.
The authors conclude that while cost is a limitation to sustained use of such automated diagnostic systems in a country like Ethiopia, the study illustrates how improved diagnostics, together with development of treatment guidelines, could reduce antibiotic use in meningitis patients.
Dec 20 BMC Infect Dis study
Company submits New Drug Applications to FDA for pneumonia antibiotic
Drug company Nabriva Therapeutics of Dublin yesterday announced it has submitted two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for the oral and intravenous (IV) formulations of lefamulin, a first-in-class, semi-synthetic pleuromutilin antibiotic that is designed for treating community-acquired bacterial pneumonia (CABP).
"The submission of the lefamulin NDAs marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to develop novel anti-infective agents that address the urgent, unmet medical need faced by patients with serious infections," said Jennifer Schranz, MD, Nabriva's chief medical officer, in a company news release. "Lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with CABP in both the hospital and ambulatory care settings."
The company said the two NDAs are supported by two phase 3 clinical trials—known as LEAP 1 and LEAP 2—that evaluated the safety and efficacy of IV and oral lefamulin compared with moxifloxacin in adults with CABP, including the option to switch from IV to oral administration and a short course of oral treatment with lefamulin. "In both LEAP 1 and LEAP 2, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the FDA and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP," the company said.
Lefamulin was also generally well tolerated in the trials. Nabriva plans to submit a marketing authorization application for lefamulin in Europe in the first quarter of 2019.
Dec 20 Nabriva news release