— Brief Report: Prospective, Controlled, Randomized, Non-Blind Comparison of Intravenous/Oral Ciprofloxacin with Intravenous Ceftazidime in the Treatment of Severe Surgical Infections Prono Lea. Det Rosa, MLD. Lus LeaL Det RosiL, MD, C. Aurievo Riosvetasco, M.D, Faxon Comuos Nese, %.0,, Victor Sava ALANS, M.D. Chiuaua Mexico Doesnt sigiteant advances in surgical techniques ‘and equipment, ‘hyperalimentation, diagnostic methods, and knowledge of bacteriology and immunol- ogy, the impact of surgical infection on patients, hos- pitals, and physicians remains the same; infections still represent a serious problem due to high cost, pa- tient ineapacity, risk of contamination, morbidity, and ‘mortality. This study compared the efficacy and salety of ciprofloxacin [1], «new quinolone with a good s trum for gram-positive eoeci, gram-negative bacteria, and some anaerobes, with a well-known third-genera- tion cephalosporin, ceftazidime, whieh also possesses a broad spectrum for gram-positive and gran tive organisms and most anaerobes. Ciprofloxacin was given intravenously during the initial part of treat- ment and then orally, trying to decrease hospital stay and cost, without endangering the clinical cou MATERIALS AND METHODS Eighty patients were enrolled i ‘each group, Patients years. Only patients with intra-abdominal and solt- tissue infections were included. All patients were hos- pitalized for at least seven days; were reeeiving some type of supportive measures including intravenously administered Muids, mechanieal ventilation, carliae support, diuretics, ‘plasma, blood, or platelets; anc had undergone one or more surgical procedures. The patients were enrolled after a complete physi- cal examination; assignment was achieved according to a randomization code. Patients receiving ceft the study, 40 in 03 anged in age from 16 to 80@Sfected: ciprofloxaci for any adverse reactions. The costs of each drug regi- men were approximated, In onder to compare two broad in the treatment of severe surgical infections, the eases included were graced according to the Surgical Infection Stratification system [2]. All eases were con- sidered to be of moderate or severe intensity. In the abdominal group, most of the patients had peritonitis with necrosis, retroperitoneal edema, bowel disten- tion, purulent adhesions, diffise involvement, and {oul odor. The soft-tissue group inclucled patients with spreading cellulitis, suppuration, necrosis, and poor general condition, In both groups, intensive care was required for most cases and was graded as follows: one organ failure (48 patients); two organ failure 20 pax tients); three organ failure (12 patients) [3]. However, cases considered as severely ill with a high Surgical Infection Stratifieation score for whom a fatal outeome was expected were not included. ‘Most of the patients had undergone one or more surgical procedures and both groups were equally :t- 22 of 40 patients (80.0 percent); ceftazidime, 31 of 40 patients (77.5 percent). The most requent types of surgery were debridement, laparot- ‘omy, common bile duct exploration, appendectomy, bowel resection, cleansing and gratt, amputation. and faseiotomy. Due to the number of suspected or identified anaes ‘obes in the ciprofloxacin group, elindamyein or metr nidazole was added in 18 of 40 (45.0 percent) patien and in eight of 40 (20.0 percent) patients in the cefta. dime group. dime were given 1 g infused over 30 minutes everyA3, eight to 12 hours, according to severity of infection, . RESULTS a for no less to seven days and up to 13 days® ‘The clinical cesults were comparable in both groups: ‘The ciprofloxacin group received 200 mg intrave-A3the resolution of signs and symptoms wus 75.0 percent, nously infused over 80 minutes every 12 hours for two gg for the ciprofloxacin and 7.0 percent for the ceftazi- to five days, followed by one 500-mig tablet every 12,” dime group; improvement occurred in 20.0 percent of hours for five to 20 days. ciprofloxacin-treated patients and 10.0 pereent of the Blood tests for renal ancl hepatic function and hema- ceftazidime group. ‘Tyeatment failed in two patients tology studies were obtained for each patient. Aerobie (5.0 pereent) receiving eiproffoxaein, and in five (12.5 and anaerobie culture specimens, sensitivity testing, percent) patients treated with ceftazidime. The differ and serum antibiotic levels were obtained on Days 0, ence was not statistically significant. A total of 102 41,3,5, 7, and the last day of treatment. All eases were _ organisms were isolated in the ciprofloxacin group and evaluated clinically and bacteriologically, as well as 94 in the ceftazidime group. They were similarly dis- ‘tributed and the main pathogens were Staplylococens aureus, Escherichia coli, Pseudomonas fluorescens, Proteus mirabilis, Enterobacter sp., Proteus sp., Streptococcus sp., Klebsiella sp., Bacteroides sp., and Peplococeus sp. z In both groups, the elimination of organisms was Frm Hs Chea cel Pau, ep Deut, oc. fst ox pte sl be acrsted fo be Lea Det Rosa Hest Cnc Gel Pree, Cale Peto Ll ye Le, Cinta, Ch, Meco November 30,1989 The American Joumal of Nedne Volume 87 (upp SA) SA-1B3SSYMPOSIUM ON CIPROPLOXACIN DEL ROSAL ET AL TABLE | Clinical and Bacteriologic Results 62 Ciprftoxacin Ceftazidime umber of Percont Number of Percont Patients oft Patients of Total Catena Reson 0 BO au 15 operant 8 20 4 100 enue 2 50 5 125 Nanber cl ‘antes of ‘ited ‘sales Ogos Oganins Bactelgiccesit ‘raticsion % a5 6 90 Perence 4 100 2 50 Betucion i 5 4 00 Supeateton 3 % 2 50 remarkable. Evadieation of causative organisms was achieved in 87.5 percent of patients given ciprofloxa- cin and $0.0 percent of patients given ceftazidime. Persistence aecurred in 10.0 percent of the eiproflox- acin- and 5.0 percent of the ceftazidime-treated pa- tients, most likely due to the high incidence of soft- tissue'infections in the ciprofloxacin group. Superin- fection developed in three ciprofloxacin-treated pa- tients and in two patients given ceftazidime (Table ‘The duration of hospitalization was shorter in the ciprofloxacin-treated patients as compared with the ceftazidime-treated patients, i.e., by 4.8 days in the intra-abdominal infeetion group and by 5,0 days for the skin and skin-structure group. Patients receiving oral treatment were discharged from the hospital ea lier than those who received ceftazidime. in addition, the total hospital cost was 11.0 pereent lower in the ciprofloxacin group. TE Patients who are admitted to the surgical wards for treatment of a serious infection or who acquire infec- tion during hospitalization are common. In_ intra abdominal infections, early diagnosis, rapid anc! effec- tive surgery, gastrointestinal decompression, fluid replacement,” use of artificial ventilation, inotropic drugs, as well as adequate use of antibioties have im- proved survival and decreased the number of comp cations, In soft-tissue infection, the use of adequate hydration, debridement, and the cleansing of necrotic areas along with antibioties are mandatory. ‘This study demonstrates that ciprofloxacin and eef- tazidime were almost, equal in efficacy and safety in the treatment of surgical infections. Both drugs were highly effective in the treatment of serious infection that required hospitalization, surgery, and supportive measures. However, the use of intravenous/oral cipro- floxacin was associated with decreased eost and hospi- talization, Specific antianaerobie drugs may be needed ty With either of the drugs studied, if anaerobes are Judged to be playing an important role in the infec- tious process. REFERENCES 1, Bass HP Thepeical ole ool Proceso 1 er roll Cogs of Gernot, sand Hong oe: Ecela Medex 157 2 OalingerE. et, th Meneei.Slin SA WD Howe RE ea shai fesien, eh Sug 165; 120 680-685. 3. Pai, hls CL: Renee azo lea wad go cel baer ton Suey 1578: 310-317 ‘Chai P Lan El, ipl OF, tt A tay rtd er aletan of tepid anirerol agers fo wat eid bn wards Bus 178 & 17 Ace Grit Gera etl Crete: an vate onc xed on He 197, 2 A 381-386 {on U Thetoyo shi at hin tatu ectns in eter: an reve nes 155 82) 224-226. ‘5R-1848 November 20,1989 The AmecanJoura of Medcine Yume 87 fupp SA)