PMID- 18684704 OWN - NLM STAT- MEDLINE DCOM- 20081020 LR - 20220310 IS - 1460-2091 (Electronic) IS - 0305-7453 (Linking) VI - 62 Suppl 1 DP - 2008 Sep TI - A Phase 3, open-label, non-comparative study of tigecycline in the treatment of patients with selected serious infections due to resistant Gram-negative organisms including Enterobacter species, Acinetobacter baumannii and Klebsiella pneumoniae. PG - i29-40 LID - 10.1093/jac/dkn249 [doi] AB - OBJECTIVES: To evaluate the efficacy and safety of tigecycline in patients with selected serious infections caused by resistant Gram-negative bacteria, or failures who had received prior antimicrobial therapy or were unable to tolerate other appropriate antimicrobials. Secondary objectives included an evaluation of the microbiological efficacy of tigecycline and in vitro activity of tigecycline for resistant Gram-negative bacteria. METHODS: This open-label, Phase 3, non-comparative, multicentre study assessed the efficacy and safety of intravenous tigecycline (100 mg initially, then 50 mg 12 hourly for 7-28 days) in hospitalized patients with serious infections including complicated intra-abdominal infection; complicated skin and skin structure infection (cSSSI); community-acquired pneumonia (CAP); hospital-acquired pneumonia, including ventilator-associated pneumonia; or bacteraemia, including catheter-related bacteraemia. All patients had infections due to resistant Gram-negative organisms, including extended-spectrum beta-lactamase-producing strains, or had failed on prior therapy or could not receive (allergy or intolerance) one or more agents from three classes of commonly used antibiotics. The primary efficacy endpoint was clinical response in the microbiologically evaluable (ME) population at test of cure (TOC). Safety data included vital signs, laboratory tests and adverse events (AEs). RESULTS: In the ME population at TOC, the clinical cure rate was 72.2% [95% confidence interval (CI): 54.8-85.8], and the microbiological eradication rate was 66.7% (95% CI: 13.7-78.8). The most commonly isolated resistant Gram-negative pathogens were Acinetobacter baumannii (47%), Escherichia coli (25%), Klebsiella pneumoniae (16.7%) and Enterobacter spp. (11.0%); the most commonly diagnosed serious infection was cSSSI (67%). The most common treatment-emergent AEs were nausea (29.5%), diarrhoea (16%) and vomiting (16%), which were mild or moderate in severity. CONCLUSIONS: In this non-comparative study, tigecycline appeared safe and efficacious in patients with difficult-to-treat serious infections caused by resistant Gram-negative organisms. FAU - Vasilev, Krasimir AU - Vasilev K AD - Clinic of Endoscopic Surgery, Military Medical Academy, 3, Georgi Sofiiski Str, 1606 Sofia, Bulgaria. FAU - Reshedko, Galina AU - Reshedko G FAU - Orasan, Remus AU - Orasan R FAU - Sanchez, Miguel AU - Sanchez M FAU - Teras, Juri AU - Teras J FAU - Babinchak, Tim AU - Babinchak T FAU - Dukart, Gary AU - Dukart G FAU - Cooper, Angel AU - Cooper A FAU - Dartois, Nathalie AU - Dartois N FAU - Gandjini, Hassan AU - Gandjini H FAU - Orrico, Russ AU - Orrico R FAU - Ellis-Grosse, Evelyn AU - Ellis-Grosse E CN - 309 Study Group LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - England TA - J Antimicrob Chemother JT - The Journal of antimicrobial chemotherapy JID - 7513617 RN - 0 (Anti-Bacterial Agents) RN - 70JE2N95KR (Tigecycline) RN - FYY3R43WGO (Minocycline) SB - IM MH - Acinetobacter Infections/*drug therapy/microbiology MH - Acinetobacter baumannii/*drug effects MH - Adult MH - Aged MH - Anti-Bacterial Agents/administration & dosage/adverse effects/pharmacology/*therapeutic use MH - *Drug Resistance, Bacterial MH - Enterobacter/*drug effects MH - Enterobacteriaceae Infections/*drug therapy/microbiology MH - Female MH - Hospitalization MH - Humans MH - Injections, Intravenous MH - Klebsiella pneumoniae/*drug effects MH - Male MH - Middle Aged MH - Minocycline/administration & dosage/adverse effects/*analogs & derivatives/pharmacology/therapeutic use MH - Tigecycline MH - Treatment Outcome FIR - Bernstein, Jack M IR - Bernstein JM FIR - Bibi, Salah IR - Bibi S FIR - Blumberg, Emily A IR - Blumberg EA FIR - Breedt, J IR - Breedt J FIR - Calistru, Petre Iacob IR - Calistru PI FIR - Campos, Maria Isabel IR - Campos MI FIR - Clara, Liliana Ofelia IR - Clara LO FIR - Carrilho, Claudia Maria Dantas de Malo IR - Carrilho CM FIR - Depuydt, Pieter IR - Depuydt P FIR - Datsenko, Alexey IR - Datsenko A FIR - Fomin, Peter IR - Fomin P FIR - French, Amalia Rodriguez IR - French AR FIR - Faria Friere, Antonio Tarcisiode IR - Faria Friere AT FIR - Ganaha, Maria Cristina IR - Ganaha MC FIR - Giamarellou, Helen IR - Giamarellou H FIR - Graham, Donald IR - Graham D FIR - Herr, Daniel L IR - Herr DL FIR - Iradell, Don IR - Iradell D FIR - Jauregi-Peredo, Luis Ernesto IR - Jauregi-Peredo LE FIR - Joshi, Manjari IR - Joshi M FIR - Kaspar, Thomas Adam IR - Kaspar TA FIR - Kolomecki, Krzysztof IR - Kolomecki K FIR - Labarca, Jaime Alejandro IR - Labarca JA FIR - Machado, Flavia Ribeiro IR - Machado FR FIR - McCue, Jack IR - McCue J FIR - Nakamura, Ana Luisa Corona IR - Nakamura AL FIR - Ninov, Borislav Tzvetanov IR - Ninov BT FIR - Noriega, Eduardo Rodriguez IR - Noriega ER FIR - Oliva, Maria Eugenia IR - Oliva ME FIR - Orasan, Remus IR - Orasan R FIR - Ostrowski, Marek IR - Ostrowski M FIR - Palacios, Guilermo M IR - Palacios GM FIR - Palmieri, Philip J IR - Palmieri PJ FIR - Peterson, Lance IR - Peterson L FIR - Reboli, Annette C IR - Reboli AC FIR - Reinhardt, John F IR - Reinhardt JF FIR - Sanchez, Miguel IR - Sanchez M FIR - Reshedko, Galina K IR - Reshedko GK FIR - Richardo, Silvana Maria de Barros IR - Richardo SM FIR - Rodriguez, Claudia Gabriela IR - Rodriguez CG FIR - Sampaio, Diana Brasil Pedral IR - Sampaio DB FIR - Siosan, Priscilla IR - Siosan P FIR - Sirvent, Joseph M IR - Sirvent JM FIR - Srinath, Latha IR - Srinath L FIR - Suh, Byungse IR - Suh B FIR - Slim, Jihad IR - Slim J FIR - Sudhindran, S IR - Sudhindran S FIR - Temporiti, Elena Rosa IR - Temporiti ER FIR - Teras, Juri IR - Teras J FIR - Vasilev, Krasimir Stefanov IR - Vasilev KS FIR - Zebolds, Silvestrs IR - Zebolds S EDAT- 2008/08/14 09:00 MHDA- 2008/10/22 09:00 CRDT- 2008/08/14 09:00 PHST- 2008/08/14 09:00 [pubmed] PHST- 2008/10/22 09:00 [medline] PHST- 2008/08/14 09:00 [entrez] AID - dkn249 [pii] AID - 10.1093/jac/dkn249 [doi] PST - ppublish SO - J Antimicrob Chemother. 2008 Sep;62 Suppl 1:i29-40. doi: 10.1093/jac/dkn249.