Gotuzzo 1989.
Methods | Randomized controlled trial
Generation of allocation sequence: block randomization with a random number table
Allocation concealment: unclear
Blinding: nil
Inclusion of all randomized participants: inadequate, 32% Duration: not reported |
|
Participants | Number of participants enrolled: 174 Number of participants analysed: 55 Loss to follow up: 7 Inclusion criteria: adults; dysentery; duration of illness less than 24 hours; informed consent Exclusion criteria: antibiotic therapy within 48 hours | |
Interventions | (1) Cotrimoxazole (160/800 mg twice a day for 5 days) (2) Norfloxacin (800 mg single dose) | |
Outcomes | (1) Days to last unformed stool (2) Number of culture positive follow up | |
Notes | Location: Peru Setting: participants were not hospitalized but followed up in the out‐patients Follow‐up period: 2 weeks Antibiotic sensitivity pattern of Shigella isolates: 84% in the cotrimoxazole group and 86% in the norfloxacin group were sensitive to cotrimoxazole; 100% sensitivity in both groups to norfloxacin Funding source(s): in part by the International Collaboration in Infectious Disease Research grant 5 P01 A120130 from the National Institute of Allergy and Infectious Diseases |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Block randomization with a random number table |
Allocation concealment? | Unclear risk | Not mentioned |
Blinding? All outcomes | High risk | Not mentioned but unlikely to be blinded as the dosage regimens of interventions were different |
Incomplete outcome data addressed? All outcomes | High risk | 174 entered the study; analysis was done on 55 (32%) patients; 62 had Shigella in culture; no data regarding participants with non‐Shigella dysentery (112) who were randomized according to the inclusion criteria. 7 patients were excluded from the culture Shigella positive 62 (5 from cotrimoxazole group due to drug resistance to the allocated drug and 2 others not mentioned). |
Free of selective reporting? | Low risk | The study's prespecified outcomes, which were of interest in this review, have been reported |
Free of other bias? | Low risk | The study appears to be free of other sources of bias |