Table 2.
Outcome Type | Outcomes Sub-Categories | Treatment group (n = 287) | ||
Gatifloxacin n = 145 | Azithromycin n = 142 | p-Value | ||
Primary | Fever Clearance Time in hours (95% CI) | 106 (94–118) | 106 (88–112) | 0.984 ˆ |
Secondary | Overall treatment failure, numbers of patients (%) | 13/145 (9) | 13/140 (9.3)¶ | 0.854 ˆ |
Did not complete full treatment course, n (%) | 0 | 2 | ||
*Clinical failure, n (%) | 6/145 (4.3) | 6/140 (4.2) | 1.000# | |
*Microbiological failure, n (%) | 2/145 (1.4) | 3/140 (2.2) | 0.680# | |
*Typhoid-fever related complications, n (%) | 0/145 (0) | 8/140 (5.7) | 0.003# | |
Gastrointestinal bleeding | 0 | 4 | ||
Pneumonia | 0 | 2 | ||
Liver dysfunction | 0 | 2 | ||
Relapse after discharge from hospital, n (%) | 4/137 (2.9) | 0/127 (0) | 0.052 ˆ | |
§Number of patients with faecal carriage at follow-up, n (%) | 1/137 (0.7) | 0/131 (0) |
*Patients can fail in more than one subcategory.
In the worst case scenario: 15/142 (10.6%) showed overall treatment failure in the azithromycin group, log rank test p = 0.570.
ˆThe p value is based on the log rank test.
The p value is based on Fisher's exact test.
Evaluated in patients who attended at least two follow-up visits.