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Abstract

In Sudan there is no sufficient data about treatment of urinary tract infection and the emerging resistance for ciprofloxacin 500mg BD and the adoption of maximum dose of ciprofloxacin 750mg  BD to overcome the resistance. That exposed the patients for more adverse effects.  The  alternative prescription of the second and third generation cephalosporin are very expensive and there is emerging  resistance of cephalosporin by Enterobacteriace bacteria secreted β-lactmase (Sibhghatulla Shaikh,Jamale Fatima&ShaziShakilet al, 2015).Therefore, this study was set out to evaluate the efficacy and safety of ciprofloxacin 500mg and TMP-SMX 80/400mg (80 mg trimethoprim and 400 mg sulfamethxazole) versus ciprofloxacin 750mg BD in the management of urinary tract infection . It was prospective, experimental, randomized, parallel-group clinical study, conducted at Elmek Nimer University Hospital, in Shendi. Sudan between August 2019 and August 2020. A total of three hundred (300) patients diagnosed with urinary tract infection were enrolled in this study. They were classified into control  group included one hundred and fifty (150 ) patients received oral ciprofloxacin 750mg BID for four (4) days for patients with uncomplicated UTI and 7 days for patients with complicated UTI . The test group included one hundred and fifty (150 ) patients received oral combination of ciprofloxacin 500mg and cotrimoxazole (TMP-SMX 80/400mg) BD for the same duration of treatment. The effectiveness endpoint and microbiological eradication rate at the test-of-cure visit in the test group (130/150; 86.7%) were superior to those in the control group (113/150; 75.3%), but with insignificant P. value of (0.275) .Clinical-cure rates at the test-of-cure visit were 88% (132/150) for the test group and 77.3% (116/150) for control group with insignificant P. value of (0.312). Safety was assessed in the intent‐to‐treat population and the incidence of drug‐related adverse events concerning GIT upset were obtained, the frequencies of nausea 13.3%, heart burn 6.7% and epigastric pain 8% and patients without GIT upset 72% were lower in the test group than in the control group (nausea 24.7%., heart burn 9.3%, epigastric pain 18% and patients without GIT up set 48%) with significant P. value of (0.007)Within two weeks post treatment, relapse of UTI in the test group was less (18 patients) than control group (34 patients) with statistically significant P. value of (0.027).Therefore, the findings of this study, which need to be verified in a large multicenter study, suggest that the combination of ciprofloxacin 500mg and co-trimoxazole 80/400mg can be an effective, safe, and affordable therapy, with minimum GIT upsets and low rate of  relapse  for UTI management  , and superior to ciprofloxacin 750mg.

Keywords

Ciprofloxacin Cotrimoxazole Combination Urinary tract infection

Article Details

How to Cite
Afaf Ali Abdelrahim, Osama Khder Ahmed, Waseem Sameer Kwami, Haghamad Allzain, & Abdelwahab Hassan Mohamed. (2021). Therapeutic efficacy and safety of ciprofloxacin and co-trimoxazole combination versus ciprofloxacin in urinary tract infection in Sudan. International Journal of Research in Pharmacology & Pharmacotherapeutics, 10(1), 58-69. https://doi.org/10.61096/ijrpp.v10.iss1.2021.58-69

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