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Therefore no information is available concerning the relapse rate after the test of cure visit.
Clinical assessments were performed at baseline and daily throughout study treatment, at the end of therapy (EOT), and at follow-up/test of cure visit (FU/TOC).
The study did not collect long-term efficacy data beyond the test of cure visit at 7-23 dafterfthe the last day of antibiotic therapy.
Modified per Protocol Set (mPP): All patients with significant bacteriuria (CFU ≥10/ml) at study entry; with test of cure visit including microbiological investigation; missing test of cure visit was rated as failure (worst case) [ 70]; doubtless randomization; and compliance (≥80% of allocated drug).
A patient is classified as treatment failure if additional antibiotic therapy is required during the initial treatment period or until the test of cure visit (TOC at day 30, primary endpoint).
Secondary analyses included bacteriologic response at the test-of cure visit by patient and isolate, as well as clinical response rates stratified as monomicrobial versus polymicrobial, and by isolate.
Per Protocol Set (PP): All patients with significant bacteriuria (CFU ≥10/ml) at study entry; with test of cure visit including microbiological investigation (except failure was already documented and additional antibiotic administered); doubtless randomization; and compliance (≥80% of allocated drug).
Pulse oximetry and/or arterial blood gases were obtained at baseline, end of therapy, early follow-up, and at the test-of-cure visits.
As shown in Table 6, clinical cure as specified was noted in 67 and 74% of patients in the 25 mg and 50 mg groups, respectively, at the test-of-cure visit (six patients in each group required further treatment between the end-of-treatment and test-of-cure visits).
The test-of-cure visit evaluating the clinical cure ranged from the end of treatment to 28 days later.
