Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis.
Escherichia coli SIG-1, a clinical strain, was the microorganism inoculated in the neutropenic mouse thigh infection model for all experiments with a microbiological endpoint (24 hours duration), and Pseudomonas aeruginosa GRP-0019, a fully-susceptible catheter isolate, for dissemination studies in the survival model (4 days long).
This is of note, since there is currently no commonly agreed definition of AECOPD and no current case definition includes a microbiological endpoint.
Discrepancies in study design, inclusion criteria, statistical methodology, and the varying definitions of both clinical and microbiological endpoints between the published studies, make it difficult to compare them, as well as to determine which regimen may be the most appropriate for patients with diabetic foot infection.
These issues are clearly important for the diagnosis and treatment of childhood tuberculosis, but are also crucial in the design of precise clinical and microbiological endpoints for trials of novel tuberculosis vaccines in these regions.
Previous work reflects the successful ability of inhaled and/or oral antibiotics to eradicate initial Pa infection, utilizing microbiological endpoints as primary outcome measures [ 9– 12].
Our microbiological endpoints will provide new information on the characteristics of these infections in urban Indigenous children at the community level given very few children presenting to primary care settings with ARI undergo bacterial and viral testing.
Secondary endpoints were: microbiological findings of BAL and relative adjustments of empiric antibiotic therapy, ABG changes, in-hospital mortality, tracheostomy, and length of hospital stay and MV.
Clinical and microbiological outcomes were considered binary endpoints and these were analyzed by using Bayesian logistic regression models.
Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the clinical cure rate 70- to 84-day post-treatment, relapse rate of UTI and adverse events or complications during 90 days of follow-up.
This effect was also observed at the lowest dose (1 mg/liter) in female mice and indicates the potential sensitivity of this endpoint for evaluating the microbiological risk of tetracycline residues.
