Table 4.
Outcome Measures in the Patients Recruited to a Murine Typhus Clinical Trial
| Outcome Measure | All | Doxycycline (7 d) | Doxycycline (3 d) |
Azithromycin (3 d) | P Valuea |
|---|---|---|---|---|---|
| Treatment failure, No. (%)b | |||||
| All patients | 20/213 (9.4) | 1/71 (1.4) | 3/71 (4.2) | 16/71 (22.5) | <.001 |
| PCR- or serology-confirmed Rickettsia typhi | 11/157 (7.0) | 0/54 | 2/54 (3.7) | 9/49 (18.4) | <.001 |
| PCR-confirmed R. typhi | 7/51 (13.7) | 0/18 | 1/18 (5.6) | 6/15 (40.0) | .002 |
| No PCR or confirmed serologic evidence of R. typhi | 9/56 (16.1) | 1/17 (5.88) | 1/17 (5.88) | 7/22 (31.8) | .06 |
| Cleared fever, No. (%)c | |||||
| All patients | 185/203 (91.1) | 69/70 (98.6) | 60/64 (93.8) | 56/69 (81.2) | <.001 |
| PCR- or serology-confirmed R. typhi | 136/146 (93.2) | 53/53 (100) | 45/47 (95.7) | 38/46 (82.6) | <.001 |
| PCR-confirmed R. typhi | 47/49 (95.9) | 17/17 (100) | 18/18 (100) | 12/14 (85.7) | .08 |
| No PCR or confirmed serologic evidence of R. typhi | 49/57 (86.0) | 16/17 (94.1) | 15/17 (88.2) | 18/23 (78.3) | .41 |
| FCT, median (IQR), hc | |||||
| All patients | 37 (24–66) | 34 (24–58) | 36 (24–51) | 48 (24–96) | .002 |
| PCR- or serology-confirmed R. typhi | 36 (24–60) | 32 (24–48) | 36 (24–60) | 43 (20–107) | .02 |
| PCR-confirmed R. typhi | 48 (30–66) | 42 (30–60) | 34 (24–60) | 66 (48–162) | .005 |
| No PCR or confirmed serologic evidence of R. typhi | 42 (24–78) | 36 (24–68) | 30 (24–50) | 70 (24–100) | .07 |
| AUC,d median (IQR), °C * h | |||||
| All | 1368 (891–2259) | 1243 (891–2016) | 1312 (792–1923) | 1639 (892–2648) | .056 |
| PCR- or serology-confirmed R. typhi | 1370 (895–2249) | 1211 (903–1834) | 1356 (681–2233) | 1616 (743–2448) | .26 |
| PCR-confirmed R. typhi | 1827 (1130–2465) | 1591 (1126–2247) | 1312 (920–2267) | 2360 (1827–4719) | .02 |
| No PCR or confirmed serologic evidence of R. typhi | 1363 (891–2499) | 1346 (455–2186) | 1117 (911–1634) | 1845 (892–3045) | .20 |
Abbreviations: AUC, area under the time-temperature curve; FCT, fever clearance time; IQR, interquartile range; PCR, polymerase chain reaction.
aFrequencies were compared using χ2 tests across 3 groups (ie, 2 degrees of freedom), clearance times were compared using log-rank tests, and AUC estimates were compared using Kruskal-Wallis tests.
bTreatment failure was assessed in 213 patients; 3 patients withdrew, 1 in each arm, before treatment failure/success could be defined.
cOf 203 patients who presented with or developed fever, fever did not clear before discharge (or withdrawal) in 18; excluded are 12 patients who were afebrile at admission and 1 who withdrew at hour 0.
dAUC for period up to FCT or last patient follow up, if fever not cleared (excluding 12 patients with no fever at admission and 1 who withdrew at hour 0). AUCs for 4 patients afebrile at admission who developed fever during follow-up were calculated from the time of first temperature ≥37.5°C.