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. 2022 Nov 24;2022(11):CD010452. doi: 10.1002/14651858.CD010452.pub2

Girgis 1995.

Study characteristics
Methods Trial design: randomized
Time period/duration of trial: unclear, before 1995
Duration of follow‐up: 4 weeks
Participants Setting: hospital
Location: Cairo, Egypt
Age: children < 16 years. Mean age (+/‐ SD) was 10.34 (+/‐ 2.89) in cefixime group, 10.05 (+/‐ 3.48) in ceftriaxone group, 9.03 (+/‐ 9.1) in the aztreonam group
Gender: male = 67, female = 57
Health status of participants: not recorded
Inclusion criteria:
  • signs and symptoms suggestive of acute enteric fever without complications of disease

Interventions
  • Cefixime: oral, 15‐20 mg/kg/day in 2 doses for a minimum of 14 days

  • Ceftriaxone: IM in gluteal region, 50‐70 mg/kg/day (maximum of 4 g) once daily for 5 days

  • Aztreonam: IM in gluteal region, 50‐70 mg/kg/dose (maximum of 8 g) every 8 h for 3 days


Antibiotics continued beyond period specified until 2 afebrile days were observed
Outcomes
  • Clinical cure: definition not specified

  • Bacteriologic eradication: not specified, but blood, urine and stool cultures taken before therapy, at end of day 3 of therapy, and 2 and 4 weeks post‐therapy

  • Time to defervescence: days until disappearance of fever (afebrile defined as fever < 37.5 °C)

  • Length of hospital stay: not defined

  • Mean laboratory values on day 10 of treatment ‐ full blood count, liver and renal function tests before treatment, end of therapy and 2 and 4 weeks post‐therapy

  • Cost analysis of therapy: calculated according to the method specified in Kerr 1992

  • Adverse events: not predefined, "side reactions" and adverse events discussed as part of results

Organism type and antimicrobial susceptibility All MDR‐S typhi (resistant to chloramphenicol, ampicillin and co‐trimoxazole by disk diffusion)
Notes 165 children enrolled and randomized, but only analysed those 124 participants with MDR‐S typhi who completed 4 weeks of follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer‐generated" list for randomization
Allocation concealment (selection bias) Unclear risk No mention of methods
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No details given
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details given
Incomplete outcome data (attrition bias)
All outcomes High risk Some loss to follow‐up ‐ exact numbers not clearly reported
Selective reporting (reporting bias) High risk Length of hospital stay prespecified as an outcome measure but no clear data were reported
Data for culture results at various time points were not reported
Other bias Low risk No obvious conflicts of interest reported