Primary and Secondary Endpoints in the Intention-to-Treat Population and Subgroups of Blood Culture–Positive and Culture-negative Patients
| Endpoint . | SXT . | Azithromycin . | Comparison, HR (95% CI) . | P Value . |
|---|---|---|---|---|
| Fever clearance time, d, median (95% CI) | ||||
| Overall ITT | 2.7 (2.6–3.3) | 2.1 (1.6–3.2) | 1.25 (.99–1.58) | .059 |
| Culture positive | 3.9 (3.0–4.4) | 4.4 (4.2–6.4) | 0.95 (.60–1.48) | .81 |
| Culture negative | 2.6 (1.4–3.3) | 1.6 (1.3–2.1) | 1.37 (1.04–1.80) | .025 |
| Treatment failure within 28 days | ||||
| Overall ITT | 36/163 | 23/163 | 0.62 (.37–1.05) | .073 |
| Probability within 28 days, % (95% CI) | 24 (17–30) | 15 (9–20) | … | |
| Culture positive | 14 (37) | 11 (37) | 0.78 (.35–1.72) | .537 |
| Probability within 28 days, % (95% CI) | 39 (21–53) | 30 (13–43) | … | |
| Culture negative | 20 (112) | 12 (120) | 0.56 (.27–1.14) | .11 |
| Probability within 28 days, % (95% CI) | 19 (11–26) | 11 (5–16) | … |
| Endpoint . | SXT . | Azithromycin . | Comparison, HR (95% CI) . | P Value . |
|---|---|---|---|---|
| Fever clearance time, d, median (95% CI) | ||||
| Overall ITT | 2.7 (2.6–3.3) | 2.1 (1.6–3.2) | 1.25 (.99–1.58) | .059 |
| Culture positive | 3.9 (3.0–4.4) | 4.4 (4.2–6.4) | 0.95 (.60–1.48) | .81 |
| Culture negative | 2.6 (1.4–3.3) | 1.6 (1.3–2.1) | 1.37 (1.04–1.80) | .025 |
| Treatment failure within 28 days | ||||
| Overall ITT | 36/163 | 23/163 | 0.62 (.37–1.05) | .073 |
| Probability within 28 days, % (95% CI) | 24 (17–30) | 15 (9–20) | … | |
| Culture positive | 14 (37) | 11 (37) | 0.78 (.35–1.72) | .537 |
| Probability within 28 days, % (95% CI) | 39 (21–53) | 30 (13–43) | … | |
| Culture negative | 20 (112) | 12 (120) | 0.56 (.27–1.14) | .11 |
| Probability within 28 days, % (95% CI) | 19 (11–26) | 11 (5–16) | … |
Abbreviations: CI, confidence interval; HR, hazard ratio (based on Weibull regression mode for fever clearance time and Cox regression for treatment failure); ITT, intention-to-treat; SXT, trimethoprim-sulfamethoxazole.
Primary and Secondary Endpoints in the Intention-to-Treat Population and Subgroups of Blood Culture–Positive and Culture-negative Patients
| Endpoint . | SXT . | Azithromycin . | Comparison, HR (95% CI) . | P Value . |
|---|---|---|---|---|
| Fever clearance time, d, median (95% CI) | ||||
| Overall ITT | 2.7 (2.6–3.3) | 2.1 (1.6–3.2) | 1.25 (.99–1.58) | .059 |
| Culture positive | 3.9 (3.0–4.4) | 4.4 (4.2–6.4) | 0.95 (.60–1.48) | .81 |
| Culture negative | 2.6 (1.4–3.3) | 1.6 (1.3–2.1) | 1.37 (1.04–1.80) | .025 |
| Treatment failure within 28 days | ||||
| Overall ITT | 36/163 | 23/163 | 0.62 (.37–1.05) | .073 |
| Probability within 28 days, % (95% CI) | 24 (17–30) | 15 (9–20) | … | |
| Culture positive | 14 (37) | 11 (37) | 0.78 (.35–1.72) | .537 |
| Probability within 28 days, % (95% CI) | 39 (21–53) | 30 (13–43) | … | |
| Culture negative | 20 (112) | 12 (120) | 0.56 (.27–1.14) | .11 |
| Probability within 28 days, % (95% CI) | 19 (11–26) | 11 (5–16) | … |
| Endpoint . | SXT . | Azithromycin . | Comparison, HR (95% CI) . | P Value . |
|---|---|---|---|---|
| Fever clearance time, d, median (95% CI) | ||||
| Overall ITT | 2.7 (2.6–3.3) | 2.1 (1.6–3.2) | 1.25 (.99–1.58) | .059 |
| Culture positive | 3.9 (3.0–4.4) | 4.4 (4.2–6.4) | 0.95 (.60–1.48) | .81 |
| Culture negative | 2.6 (1.4–3.3) | 1.6 (1.3–2.1) | 1.37 (1.04–1.80) | .025 |
| Treatment failure within 28 days | ||||
| Overall ITT | 36/163 | 23/163 | 0.62 (.37–1.05) | .073 |
| Probability within 28 days, % (95% CI) | 24 (17–30) | 15 (9–20) | … | |
| Culture positive | 14 (37) | 11 (37) | 0.78 (.35–1.72) | .537 |
| Probability within 28 days, % (95% CI) | 39 (21–53) | 30 (13–43) | … | |
| Culture negative | 20 (112) | 12 (120) | 0.56 (.27–1.14) | .11 |
| Probability within 28 days, % (95% CI) | 19 (11–26) | 11 (5–16) | … |
Abbreviations: CI, confidence interval; HR, hazard ratio (based on Weibull regression mode for fever clearance time and Cox regression for treatment failure); ITT, intention-to-treat; SXT, trimethoprim-sulfamethoxazole.
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