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Twenty-two adult patients with osteomyelitis due to Pseudomonas aeruginosa were enrolled in an open, prospective cooperative study to determine the efficacy of oral ciprofloxacin therapy in a dosage of 750 mg twice a day. Twenty patients received a complete course of treatment and could be assessed for efficacy. There were 12 men and 8 women, with a mean age of 55 years. Six patients had undergone previous, unsuccessful attempts at therapy. Eight patients had clinically important underlying conditions. The most common sites of infection were the sternum (six patients), hip (four patients), vertebrae (four patients), and tibia (two patients). Initial surgical debridement was performed in 18 of the 20 assessable patients. The mean duration of treatment was 2.85 months (range, 1 to 4 months), and that of the follow-up was 27 months (range, 6 to 52 months). Cure was achieved in 19 of the 20 (95%) patients. The only significant adverse effect (which prompted discontinuation of therapy) was severe nausea in one case. Oral ciprofloxacin coupled with adequate debridement is an effective, convenient, and safe therapy in patients with acute and subacute P. aeruginosa osteomyelitis.
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PMID:Oral ciprofloxacin treatment of Pseudomonas aeruginosa osteomyelitis. 236 Aug 23

The efficacy and safety of oral ciprofloxacin, a fluoroquinolone, were evaluated in the treatment of infection due to Pseudomonas aeruginosa. 96 infections in 71 patients were treated. Substantial underlying disease was present in most of the patients, and 25 (35%) were seriously ill. 52% of pseudomonas isolates were carbenicillin-resistant, and 31% gentamicin-resistant. The overall clinical response rate was 77%-28 of 35 exacerbations of cystic fibrosis respiratory disease, 17 of 19 urinary infections, 4 of 6 osteomyelitis, and 11 of 15 soft tissue infections. The bacteriological cure rate was 34%-0 of 35 cystic fibrosis, 4 of 17 respiratory infections, 17 of 19 urinary infections, 4 of 6 osteomyelitis, and 8 of 15 soft tissue infections. Ps aeruginosa developed resistance to ciprofloxacin in 25 of 96 infections. Side-effects were generally slight with nausea in 14 (15%) the most common, and there were only two substantial superinfections.
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PMID:Oral ciprofloxacin therapy of infections due to Pseudomonas aeruginosa. 287 Mar 13

Gram-negative osteomyelitis frequently responds poorly to conventional therapy. Ciprofloxacin displays excellent in vitro activity against gram-negative bacilli and offers the potential for outpatient therapy. In this ongoing study, ciprofloxacin therapy is being evaluated for the treatment of gram-negative osteomyelitis. Twenty-three patients (16 men and seven women) have been treated under the protocol (750 mg orally twice daily for 1.5 to six months), and 14 patients have completed therapy. All patients had either growth on bone cultures from an open or percutaneous biopsy, or an arthrocentesis to confirm the diagnosis. Involved sites included ankle or tibia (seven patients), vertebra (four patients), hip (five patients), metatarsal (four patients), phalanx (two patients), and metacarpal (one patient); 16 patients had chronic disease, and seven patients had acute disease. Patients had a total of 28 gram-negative bacilli, 12 gram-positive cocci, and one anaerobic gram-negative rod, for an average of 1.8 pathogens per patient. Eighteen of the 28 gram-negative bacilli were Pseudomonas species. The geometric mean minimal inhibitory concentration for all the gram-negative bacilli was 0.15 microgram/ml. The geometric mean minimal inhibitory concentration for the gram-positive isolates was 0.41 microgram/ml. All patients who completed therapy experienced a cure, with a mean follow-up of 6.1 months. Infections in all patients, except for two who are still taking ciprofloxacin, are resolving, both clinically and radiologically. One patient who was not eligible for the protocol experienced a superinfection with methicillin-resistant Staphylococcus aureus. Side effects have included urticaria, lethargy, nausea, and transient elevations of liver and renal function test results. Overall, ciprofloxacin therapy was well tolerated. This study suggests that ciprofloxacin holds promise for the outpatient treatment of gram-negative osteomyelitis.
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PMID:Oral ciprofloxacin therapy for gram-negative bacillary osteomyelitis. 355 43

The efficacy and toxicity of ciprofloxacin, an orally administered fluoroquinolone, were evaluated in 24 infections in 23 patients with osteomyelitis caused by aerobic gram-negative bacilli. The diagnosis was confirmed by surgical findings and the results of bone biopsy and culture of bone or deep soft tissue. The aerobic gram-negative bacilli were Pseudomonas aeruginosa (15 isolates), Serratia marcescens (five isolates), Escherichia coli (three isolates), Enterobacter species (three isolates), Proteus mirabilis (one isolate), Pseudomonas fluorescens (one isolate), and Klebsiella pneumoniae (one isolate). Minimal bactericidal concentrations (MBCs) were 1.56 micrograms/ml or less for all but one isolate. Nine infections were polymicrobial, involving aerobic gram-positive cocci or anaerobes in addition to aerobic gram-negative bacilli. Additional antibiotics to which the aerobic gram-negative bacilli were resistant were given when the additional organisms were resistant to ciprofloxacin. Patients received 750 mg of ciprofloxacin twice daily for a mean of 62 days. Peak serum levels of ciprofloxacin were at least threefold higher than the MBCs in 20 of 24 patients. Twenty of 22 infections in which a full course of therapy was completed were without evidence of active disease at one to 17 months posttreatment. A sternotomy wound infection relapsed after eight weeks of therapy with a newly resistant S. marcescens strain, and an infection of a compound fracture relapsed two months posttreatment with a still sensitive P. aeruginosa strain. Toxicity was minimal in most patients: eosinophilia (six patients), nausea (eight patients), mild elevation in transaminase levels (three patients), pruritus (one patient), diarrhea (two patients), thrush (two patients), rash (two patients), and mild leukopenia (one patient). Two additional patients had severe side effects (vertigo in one and acute renal failure in another) that required discontinuation of ciprofloxacin therapy. Overall, ciprofloxacin is a promising agent for the oral treatment of gram-negative bacillary osteomyelitis.
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PMID:Clinical efficacy of ciprofloxacin therapy for gram-negative bacillary osteomyelitis. 355 45

Intravenous ciprofloxacin was administered to 54 patients who were either critically ill or in whom oral administration was not possible. The 31 males and 23 females ranged in age from 20 to 89 years (mean, 53.2 +/- 17.8 years). Patients had "difficult-to-treat" infections, i.e., respiratory infections (15), abscesses (four intraabdominal, three lung, two soft tissue, and one intrahepatic), deep soft tissue infections (10), chronic post-traumatic osteomyelitis in exacerbation (nine), upper urinary tract infection (five), malignant external otitis (two), catheter-related bacteremia (two), and infectious endocarditis (one). Thirty patients (56 percent) had serious associated medical problems. Pathogens included Pseudomonas aeruginosa (38 isolates), Acinetobacter species (10 isolates), Enterobacter cloacae (eight isolates), Escherichia coli (two isolates), Proteus mirabilis (one isolate), Kingella kingae (one isolate), Bacteroides fragilis (eight isolates), and Peptostreptococcus species (five isolates). Minimal inhibitory concentrations of ciprofloxacin ranged from 0.003 to 2 micrograms/ml. In 39 patients, the isolated microorganisms were multi-resistant; resistance included ceftazidime and amikacin in 32 patients. In 24 patients, ciprofloxacin was given exclusively by the intravenous route at a dose of 200 mg every 12 hours; in 30 patients, treatment was completed after discontinuation of the parenteral drug with the oral preparation of ciprofloxacin at a dose of 750 mg every 12 hours. The duration of parenteral treatment ranged from six to 40 days (mean, 14.9 days). A successful clinical response was observed in 49 patients (91 percent), while five (9 percent) failed to show a response. Bacteriologic outcomes were as follows: eradication of pathogen in 33 patients (61.1 percent), persistence in 18 (33.3 percent), and relapse in three (5.6 percent), with development of resistance to ciprofloxacin in nine patients (16.7 percent) and superinfection in two patients (3.7 percent). Side effects included vein irritation at the site of the infusion (three patients), abnormal elevation in liver enzyme levels (two patients), reversible renal failure (one patient), and nausea (one patient). Parenteral ciprofloxacin is a safe, well-tolerated, and effective therapy for the critically ill patient, and can be replaced with the oral form when clinically appropriate.
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PMID:Use of intravenous ciprofloxacin in difficult-to-treat infections. 355 59

Thirty-four patients were treated with intravenous ciprofloxacin. Thirty infections occurring in 28 patients were assessable for the efficacy analysis. The drug dosage was 300 mg every 12 hours in 19 patients and 200 mg intravenously every 12 hours in nine patients. Twelve patients were also given ciprofloxacin orally after initial intravenous therapy. The mean duration of total therapy was 31 days. The overall clinical response rate was 87 percent, and the bacteriologic response rate was 70 percent. Favorable responses were observed in 10 of 12 patients with osteomyelitis/septic arthritis; seven of eight with soft tissue infection; four of four with pneumonitis; one of two with cystic fibrosis; and four of four with urinary tract infections. Resistance to ciprofloxacin developed in three Pseudomonas aeruginosa isolates. Toxicity was minor: phlebitis occurred in six patients, nausea in six, and rash in one. Intravenously administered ciprofloxacin or intravenous ciprofloxacin followed by oral ciprofloxacin is a safe and effective therapy for serious infections.
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PMID:Treatment of serious infections with intravenous ciprofloxacin. 355 62

Thirty-four patients with osteomyelitis were treated for a mean of 32.5 days with 2 to 4 g per day of imipenem/cilastatin. Twenty-six infections involving the lower extremities were associated with accidents and prosthesis implantation, and 19 of 34 patients had more than one organism isolated. Gram-positive and gram-negative organisms were equally represented, but follow-up bone culture samples showed only 11 percent of gram-positive organisms persisted versus 23 percent of gram-negative organisms. Seventy-four percent of patients were cured or improved, and failures were related to resistant organisms and the inability to perform adequate surgical debridement. Adverse drug side effects included nausea, diarrhea, liver enzyme elevations, and neutropenia, but discontinuation of treatment was required in only three patients. Imipenem/cilastatin holds promise as monotherapy in complicated polymicrobial osteomyelitis.
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PMID:Imipenem/cilastatin in the treatment of osteomyelitis. 385 7

Monotherapy of osteomyelitis with the newer broad-spectrum beta-lactam antibiotics has become attractive because of the efficacy, safety, and cost of these antibiotics when compared with conventional combination therapy. Imipenem/cilastatin is a recent and promising addition to this antibiotic family. Experience with imipenem/cilastatin and that reported for cefotaxime, ceftazidime, and ceftizoxime in the treatment of biopsy-proved osteomyelitis was compared, using data from published reports from five centers. Two hundred forty-three patients were evaluable: 34 were treated with imipenem/cilastatin, 84 with cefotaxime, 122 with ceftazidime, and 33 with ceftizoxime. Staphylococcus aureus was isolated by 80 bone cultures and was the most common single species encountered. There were 75 isolates of Pseudomonas aeruginosa, 113 mixed Enterobacteriaceae species, 115 mixed gram-positive and -negative isolates of miscellaneous species, and 30 anerobic isolates. Polymicrobial infection was present in 101 cases (41.6 percent). Failure rates were similarly low in all groups (10 to 30 percent). However, resistance developed during therapy in all groups with P. aeruginosa. Side effects were predictably few, but reversible neutropenia, pseudomembranous colitis due to Clostridium difficile, and nausea required therapy to be discontinued in seven patients. Imipenem/cilastatin should prove to be a very effective and relatively safe single agent for treatment of osteomyelitis.
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PMID:Role for newer beta-lactam antibiotics in treatment of osteomyelitis. 385 12

Imipenem-cilastatin was given in doses of 1 g intravenously every 6 h to 31 patients. Twenty-five patients, with 27 infections, were clinically evaluable and received 20 to 210 g of imipenem for a duration of 5 to 56 days (average 16.3 days). Infections included seven cases of osteomyelitis, seven of bacteremia, five of cellulitis, two of pneumonia, three of pelvic cellulitis, two of intraabdominal abscess, and one each of empyema, mediastinitis, and endometritis. Fifty-five percent of the infections were caused by gram-negative bacilli, 33% were due to gram-positive organisms, and 10% were caused by anaerobes. Twenty-two patients (81%) were cured, three improved, one relapsed, and one became superinfected with a resistant organism. In 5 of 11 cases with Pseudomonas aeruginosa, the imipenem MIC for organisms isolated by the end of treatment was higher than it was initially, raising concern that imipenem should not be used alone to treat Pseudomonas aeruginosa infections. Twenty-one patients had no adverse reaction; of the remaining 10 patients, 4 had nausea, 1 had urticaria, and 6 had mild abnormalities in hepatic function; three episodes of diarrhea included two with Clostridium difficile toxin in stool and one with pseudomembranous colitis, as determined by sigmoidoscopy. Levels of creatinine, hemoglobin, leukocytes, platelets, prothrombin, and urine components were unchanged. Imipenem-cilastatin is a clinically effective antibiotic with freedom from nephrotoxicity and hematological abnormalities in the large doses used in this study.
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PMID:Safety and efficacy of high-dose treatment with imipenem-cilastatin in seriously ill patients. 386 Jan 87

Imipenem/cilastatin is the first of a new class of beta-lactam antibiotics called carbapenems. The antibacterial spectrum of imipenem exceeds any antibiotic investigated to date and includes gram-positive, gram-negative, and anaerobic organisms. Only methicillin-resistant organisms, Strep. faecium, Pseudomonas cepacia, and Pseudomonas maltophilia have been shown to be resistant. Imipenem is administered in a 1:1 ratio with cilastatin, which inhibits a renal enzyme (dehydropeptidase) and improves urinary recovery of imipenem. The elimination half-life of both compounds is 1.0 hours and recommended doses are 0.25-0.5 g iv q6h. Adverse events are similar in nature and incidence to beta-lactam antibiotics, with phlebitis/thrombophlebitis, diarrhea, nausea, skin rash, and elevations of hepatic enzymes most common. Clinical studies in phase II and III trials have shown imipenem/cilastatin to be effective in soft tissue infections, endocarditis, obstetrics and gynecology, complicated urinary tract infections, mixed anaerobic-aerobic infections, osteomyelitis, bacteremias, and pneumonias. Several comparative clinical trials have shown imipenem/cilastatin to be equal in efficacy to combination therapy. Imipenem/cilastatin may prove to be an alternative to combination antibiotic therapy because of its extremely broad spectrum of activity.
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PMID:Imipenem/cilastatin: the first carbapenem antibiotic. 391 Mar 85


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