Table 1. Characteristics of the Patients at Baseline (Modified Intention-to-Treat Population).*.
| Characteristic | Doxycycline (N = 265) | Azithromycin (N = 263) | Combination Therapy (N = 266) | All Patients (N = 794) |
|---|---|---|---|---|
| Age — yr | ||||
| Median (IQR) | 48 (35–59) | 49 (38–60) | 46 (35–59) | 48 (36–59) |
| Range | 16–87 | 15–95 | 15–92 | 15–95 |
| Male sex — no. (%) | 140 (53) | 145 (55) | 145 (55) | 430 (54) |
| Coexisting illness — no. (%) | ||||
| Diabetes mellitus | 43 (16) | 32 (12) | 41 (15) | 116 (15) |
| Systemic hypertension | 36 (14) | 33 (13) | 28 (11) | 97 (12) |
| Cerebrovascular disease | 4 (2) | 5 (2) | 2 (1) | 11 (1) |
| Cardiovascular disease | 3 (1) | 5 (2) | 5 (2) | 13 (2) |
| Chronic lung disease | 5 (2) | 6 (2) | 0 | 11 (1) |
| Chronic kidney disease | 2 (1) | 4 (2) | 1 (<1) | 7 (1) |
| Chronic liver disease | 0 | 3 (1) | 0 | 3 (<1) |
| Smoking history — no. (%) | 55 (21) | 58 (22) | 47 (18) | 160 (20) |
| Alcohol consumption ≥3 days/wk — no. (%) | 61 (23) | 70 (27) | 60 (23) | 191 (24) |
| Duration of fever — days† | ||||
| Median (IQR) | 7 (5–10) | 7 (5–10) | 7 (5–10) | 7 (5–10) |
| Range | 1–20 | 1–20 | 1–15 | 1–20 |
| Complications — no. (%) | ||||
| Cardiovascular‡ | 110 (42) | 105 (40) | 119(45) | 334 (42) |
| Respiratory§ | 165 (62) | 164 (62) | 167 (63) | 496 (62) |
| Hepatic: total bilirubin, >2 mg/dl | 150 (57) | 146 (56) | 129 (48) | 425 (54) |
| Renal: creatinine, >2 mg/dl | 84 (32) | 82 (31) | 70 (26) | 236 (30) |
| Neurologic¶ | 63 (24) | 48 (18) | 50 (19) | 161 (20) |
| Abnormal sensorium‖ | 75 (28) | 78 (30) | 69 (26) | 222 (28) |
| Hematologic: platelets, <20,000/mm3 | 30 (11) | 41(16) | 39 (15) | 110 (14) |
| Median no. of organs involved (IQR) | 2 (1–3) | 2 (2–3) | 2 (1–3) | 2 (1–3) |
| Positivity for Orientia tsutsugamushi on PCR — no. (%) | 238 (90) | 248 (94) | 249 (94) | 735 (93) |
To convert the values for bilirubin to micromoles per liter, multiply by 17.1. To convert the values for creatinine to micromoles per liter, multiply by 88.4. IQR denotes interquartile range, and PCR polymerase chain reaction.
Data regarding fever duration were available for 261 patients in the doxycycline group, 260 in the azithromycin group, and 262 in the combination-therapy group.
Cardiovascular complications included hypotension (systolic blood pressure, <90 mm Hg), myocarditis, and new-onset arrhythmia.
Respiratory complications included an oxygen saturation of less than 92% with infiltrates on chest radiography and a ratio of partial pressure of oxygen to the fraction of inspired oxygen of less than 200.
Neurologic complications (including new-onset seizures, meningitis, and meningoencephalitis) were rated as severe or moderate (<12) on the Glasgow Coma Scale, which ranges from 3 to 15, with higher scores indicating greater awareness.
Abnormal sensorium was defined as a value of less than 15 on the Glasgow Coma Scale.