alatrofloxacin and Pneumonia--Bacterial

IV/PO moxifloxacin was evaluated in the treatment of hospitalized patients with severe community-acquired pneumonia (CAP).. Data were pooled from two prospective, randomized studies. In the multinational study, patients received 7-14 days IV/PO moxifloxacin 400 mg QD or IV/ PO amoxicillin clavulanate 1200/625 mg TID +/- IV/PO clarithromycin 500 mg BID. In the North American study, patients received 7-14 days IV/PO moxifloxacin 400 mg QD, IV/ PO alatrofloxacin/trovafloxacin 200 mg QD, or IV/PO levofloxacin 500 mg QD. The primary endpoint was clinical success at the test-to-cure visit. Severe CAP was defined according to the 1993 ATS criteria.. In the clinically valid population, clinical success rates were 88% (167/190) for moxifloxacin- and 83% (155/186) for comparator-treated patients (95% CI = -1.9%, 12.2%). Corresponding clinical success rates for the microbiologically valid population were 87% (59/68) and 84% (54/64), respectively (95% CI = 8.6%, 15.0%). A switch from IV to PO therapy was made by day 5 of therapy for 73% of moxifloxacin- vs. 60% of comparator-treated patients (P < 0.01). Clinical success rates were similar in a retrospective analysis using the revised 2001 ATS definition of severe CAP. Mortality rates were 6% (15/241) and 10% (24/238) in the moxifloxacin and comparator treatment groups, respectively. The incidence of drug-related adverse events was similar in both treatment groups.. Sequential IV/PO moxifloxacin 400 mg QD is as safe and effective as other fluoroquinolones and a beta-lactam/macrolide combination for treating hospitalized patients with severe CAP.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aza Compounds; Clarithromycin; Community-Acquired Infections; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Fluoroquinolones; Humans; Male; Middle Aged; Moxifloxacin; Naphthyridines; Pneumonia, Bacterial; Quinolines; Retrospective Studies; Treatment Outcome

To report the development of severe thrombocytopenia during alatrofloxacin therapy.. A 54-year-old Native American woman was admitted for pneumonia after completing a 10-day course of loracarbef 200 mg po bid. On admission, the woman was hypoxic (PO2 56 mm Hg) and had a platelet count of 408 x 10(3)/mm3. Alatrofloxacin 300 mg iv piggyback qd was initiated in the emergency department. The patient's condition gradually improved during the next three days. While preparing for discharge on hospital day 4, the patient developed epistaxis that lasted approximately three hours. Laboratory testing revealed a platelet count of 7 x 10(3)/mm3; stable red blood cell count, hemoglobin, and hematocrit values; and a normal white blood cell count. Alatrofloxacin therapy was discontinued and azithromycin was initiated on hospital day 4. Methylprednisolone 125 mg iv piggyback every 12 hours was initiated on hospital day 5. The platelet count fell to 2 x 10(3)/mm3 on hospital day 5 and then began to rise, reaching 60 x 10(3)/mm3 when the patient was discharged on hospital day 8.. Numerous infectious, disease-related, environmental, and pharmacologic factors may cause thrombocytopenia. Drug-induced thrombocytopenia usually develops during the first two weeks of therapy and resolves within one week of drug discontinuation. Thrombocytopenia occurred in <1% of more than 7000 patients receiving alatrofloxacin or trovafloxacin during clinical trials.. The time course of this patient's development of and recovery from thrombocytopenia suggests that it was induced by alatrofloxacin. Clinicians should monitor patients receiving alatrofloxacin or trovafloxacin for signs and symptoms of bleeding and thrombocytopenia.

Topics: Anti-Infective Agents; Female; Fluoroquinolones; Humans; Middle Aged; Platelet Count; Pneumonia, Bacterial; Thrombocytopenia