Haltalin 1973.
Methods | Randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: no
Blinding: unclear
Inclusion of all randomized participants: adequate, 100% Duration: not reported |
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Participants | Number of participants enrolled: 36 Number of participants analysed: 36 Loss to follow up: nil Inclusion criteria: infants and children; acute diarrhoeal disease; presumptive bacteriologic diagnosis of shigellosis; written informed consent from responsible legal guardian Exclusion criteria: infants under 1 month of age; known drug allergy; requiring specific antimicrobial therapy for concurrent infection | |
Interventions | (1) Nalidixic acid (13.75 mg/kg, orally, every 6 hours for 5 days)
(2) Ampicillin (25 mg/kg, orally, every 6 hours for 5 days) Other interventions: Symptomatic treatment for fever and convulsions was ordered as necessary and was similar for both groups Fluid and electrolyte therapy and oral alimentation were given according to ward routine and was similar for both groups |
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Outcomes | (1) Number culture positive > 48 hours after start of treatment (2) Number culture positive > 5 days after start of treatment (3) Relapse (4) Number of days until culture negative (5) Diarrhoea > 5 days after start of treatment (6) Removed from protocol due to worsening (7) Number of days diarrhoea after start of treatment (8) Days until afebrile after start of treatment | |
Notes | Location: United States of America Setting: hospital, in‐patient based trial Follow‐up period: 5 days Antibiotic sensitivity pattern of Shigella isolates: 17/17, 100%, in the nalidixic acid group were sensitive to nalidixic acid and 19/19, 100%, in the ampicillin group were sensitive to ampicillin. Nalidixic acid sensitivity in the ampicillin group and ampicillin sensitivity in the nalidixic group is not reported. Funding source(s):
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | "...randomly assigned"; but the method of sequencing not mentioned. In a previous trial done by the same author (Haltalin 1967) randomization was done based on the terminal digit number of the hospital record. The author could not be contacted for details since there was no mail ID. The journal's present editorial team did not have any details of the study. |
Allocation concealment? | Unclear risk | Not mentioned |
Blinding? All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data addressed? All outcomes | Low risk | No missing outcome data |
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 |