Active substance: Ciprofloxacin
Temperature was recorded. Sputum was collected for culture at the admission visit and, if available, at subsequent visits.
Blood and urine were collected for safety tests at the admission visit and at the first visit after therapy. If abnormalities were seen at the first visit after therapy, a repeat test was performed at the next visit.
A brief physical examination was performed at study entry and at all visits after therapy. Patients were queried in a non-specific fashion for adverse events at each visit. Clinical cure was defined as absence or significant remission of all admission signs and symptoms.
Admission pathogens that were not present at the follow-up visit were classified as eradicated, and those that remained were defined as persistent. If clinical improvement occurred such that no sputum was available for culture at follow-up visits, the pathogen was considered to have been eradicated.
Superinfection was defined as the appearance of a new pathogen between the admission and TOC visits with a concomitant worsening of clinical condition. Reinfection was deemed to have occurred if any new pathogen was seen between the TOC visit and the LTFU visit with an accompanying worsening of clinical condition.
Patients were deemed clinically evaluable if they had clinical evidence of AECB without radiographic evidence of pneumonia, had no resistant organisms at baseline, took study drug as prescribed, did not take non-study systemic antibacterial therapy for concurrent infections and were clinically assessed on the days specified in the protocol.
Therapy duration and prior antibacterial rules described above for evaluable patients also applied for clinically evaluable patients. Patients were not excluded from this data set as a result of inadequate microbiological data i.
Patients in the intent-to-treat population were all those randomized to treatment. Statistical analyses The study was designed with a sample size of 190 evaluable patients per treatment group.
All statistical tests were performed with SAS software. Results Of the 548 patients enrolled, 278 were randomized to the cefdinir group and 270 to the cefprozil group.
Patients were evenly distributed by gender, race and age across both treatment groups. The median time for which patients took study medication was 5 days for cefdinir and 10 days for cefprozil. The presence and severity of clinical signs and symptoms at study admission were similar for patients in the two treatment groups data not shown.
All investigators received Institutional Review Board approval for the protocol before beginning the study and all patients or their guardians provided written informed consent before study entry.
The study was conducted according to the Declaration of Helsinki. Microbiological investigations All patients produced a sputum specimen at study entry.
Cefprozil was tested by disc diffusion only. Published standards were used for the cefprozil susceptibility breakpoints.
Penicillin susceptibility results were used to define susceptibility of Streptococcus pneumoniae to cefdinir and cefprozil. Appropriate strains Haemophilus spp. Antimicrobial therapy Patients were randomized 1:1 to either cefdinir 300 mg bd or cefprozil 500 mg bd.
Cefprozil was chosen as the comparator agent because it is approved for the treatment of patients with AECB and for more severe lower respiratory infections such as pneumonia.