Table 4.
Fever clearance time (secondary endpoint) overall and in predefined subgroups
|
Gatifloxacin |
Ceftriaxone |
Acceleration factor (95% CI), p value | Heterogeneity test (pinteraction value) | ||||
|---|---|---|---|---|---|---|---|
| n | Median (IQR) days | n | Median (IQR) days | ||||
| All patients (modified intention-to-treat population) | 120 | 2·43 (1·09−4·56) | 119 | 2·93 (1·44−5·12) | 0·89 (0·72−1·11); p=0·31 | ||
| Culture-negative or culture-positive population | <0·0001 | ||||||
| Culture negative | 58 | 1·12 (0·39−2·58) | 65 | 3·03 (1·31−5·85) | 0·44 (0·30−0·65); p<0·0001 | ||
| Culture positive | 62 | 4·21 (2·63−6·10) | 54 | 2·78 (1·62−4·26) | 1·42 (1·15−1·76); p=0·001 | ||
| Pathogen (culture-confirmed population) | 0·57 | ||||||
| Salmonella Paratyphi A | 19 | 3·68 (2·50−4·98) | 16 | 2·24 (1·18−3·69) | 1·31 (0·88−1·94); p=0·19 | ||
| Salmonella Typhi | 43 | 4·51 (2·79−6·58) | 38 | 3·03 (1·86−4·46) | 1·47 (1·15−1·88); p=0·002 | ||
| Age (modified intention-to-treat population) | 0·29 | ||||||
| <16 years | 32 | 3·02 (1·70−4·75) | 36 | 2·23 (0·93−4·46) | 1·08 (0·72−1·60); p=0·72 | ||
| ≥16 years | 88 | 2·22 (0·92−4·45) | 83 | 3·25 (1·70−5·41) | 0·83 (0·64−1·08); p=0·16 | ||
| Age (culture-confirmed population) | 0·46 | ||||||
| <16 years | 21 | 3·82 (2·45−5·43) | 16 | 3·04 (1·94−4·32) | 1·26 (0·90−1·76); p=0·18 | ||
| ≥16 years | 41 | 4·43 (2·77−6·43) | 38 | 2·66 (1·47−4·22) | 1·51 (1·15−1·97); p=0·003 | ||
| Sex (modified intention-to-treat population) | 0·99 | ||||||
| Female | 21 | 2·41 (1·13−4·39) | 38 | 2·78 (1·34−4·94) | 0·89 (0·56−1·41); p=0·61 | ||
| Male | 99 | 2·44 (1·09−4·59) | 81 | 2·99 (1·48−5·20) | 0·89 (0·68−1·14); p=0·35 | ||
| Sex (culture-confirmed population) | 0·68 | ||||||
| Female | 11 | 4·27 (3·12−5·47) | 17 | 3·06 (1·93−4·41) | 1·25 (0·86−1·83); p=0·25 | ||
| Male | 51 | 4·18 (2·56−6·16) | 37 | 2·66 (1·50−4·17) | 1·46 (1·13−1·89); p=0·004 | ||
| Recruitment date (modified intention-to-treat population) | 0·09 | ||||||
| Before April 1, 2013 | 62 | 2·30 (1·10−4·09) | 59 | 2·79 (1·16−5·55) | 0·74 (0·53−1·03); p=0·08 | ||
| April 1, 2013, or later | 58 | 2·60 (1·12−5·04) | 60 | 3·05 (1·76−4·69) | 1·09 (0·82−1·45); p=0·56 | ||
| Recruitment date (culture-confirmed population) | 0·12 | ||||||
| Before April 1, 2013 | 33 | 3·88 (2·63−5·26) | 28 | 2·54 (1·31−4·27) | 1·21 (0·90−1·63); p=0·22 | ||
| April 1, 2013, or later | 29 | 4·68 (2·82−6·97) | 26 | 3·00 (1·96−4·20) | 1·68 (1·26−2·23); p=0·0004 | ||
| MIC against ciprofloxacin (culture-confirmed population) | 0·02 | ||||||
| <0·12 μg/mL | 4 | 2·55 (1·82−3·32) | 3 | 4·98 (4·09−5·82) | 0·58 (0·35−0·94); p=0·028 | ||
| 0·12−2·00 μg/mL | 45 | 3·88 (2·67−5·21) | 46 | 2·63 (1·49−4·12) | 1·24 (0·99−1·56); p=0·06 | ||
| >2·00 μg/mL* | 10 | 8·20 (5·99−10·50) | 4 | 3·66 (2·84−4·46) | 2·36 (1·58−3·51); p=<0·0001 | ||
| MIC against gatifloxacin (culture-confirmed population) | 0·049 | ||||||
| ≤1·00 μg/mL | 49 | 3·76 (2·56−5·08) | 49 | 2·75 (1·58−4·27) | 1·17 (0·94−1·45); p=0·15 | ||
| >1·00 μg/mL | 10 | 8·20 (5·99−10·50) | 4 | 3·66 (2·84−4·46) | 2·36 (1·58−3·51); p<0·0001 | ||
Percentages not added to this table because the denominators for populations change and are not clearly specified. MIC=minimum inhibitory concentration.
*
Among the 14 strains, two had a ciprofloxacin MIC of 24 μg/mL and 12 had an MIC >32 μg/mL.