Azithromycin in severe malaria bacterial co-infection in African children (TABS-PKPD): a phase II randomised controlled trial

Table 2 Primary and secondary outcomes

	10 mg/kg	15 mg/kg	20 mg/kg	15 vs 10 estimate; p value	20 vs 10 estimate; p value
Primary outcomes
Change in CRP at 72 h—mean (95% CI)^a	− 65.8 (− 74.5, − 57.1)	− 51.2 (− 59.5, − 42.9)	− 64.8 (− 73.1, − 56.5)	14.6 (2.6, 26.6); 0.02^b	1.0 (− 11.0, 13.0); 0.87^b
Deaths by 7 days—n (%)	1 (3%)	0 (0%)	1 (3%)
Pathogen found at day 7—n (%)^c	0 (0%)	0 (0%)	1ⁱ (3%)
Microbiological cure^d
7 day survival and microbiological cure				–	0.50 (0.04, 5.79); 0.58^e
Secondary outcomes
Mortality—n (%) cumulative deaths
48 h	0 (0%)	0 (0%)	1 (3%)
7 days	1 (3%)	0 (0%)	1 (3%)		1.00 (0.06, 15.99); 1.00^f
28 days	1 (3%)	0 (0%)	1 (3%)		1.00 (0.06, 15.99); 1.00^f
90 days	1 (3%)	1 (3%)	1 (3%)	0.96 (0.06, 15.37); 0.98^f	0.98 (0.06, 15.67); 0.99^f
Time to discharge—median (IQR) days	3 (3, 4)	3 (3, 4)	3 (3, 3)	1.08 (0.81, 1.43); 0.60^g	1.08 (0.78, 1.49); 0.66^g
Time to readmission—n (%) of children readmitted	2 (6%)	2 (6%)	3 (9%)	0.94 (0.13, 6.65); 0.95^h	1.40 (0.23, 8.60); 0.72^h

^aMean change in CRP between day 0 and day 3, estimated by linear regression adjusted for baseline values
^bMean difference between arms estimated by linear regression adjusted for baseline values
^cTwo children had a missing microbiology result at day 7
^dThe endpoint for microbiological cure was not calculated since only one pathogen was identified at baseline among cases
^eOdds ratio estimated by logistic regression
^fHazard ratio from Cox proportional hazards model
^gSubhazard ratio of time from randomisation to discharge from competing risks model with death before discharge treated as a competing risk
^hSubhazard ratio of time from discharge to readmission from competing risks model with death before readmission treated as competing risk
ⁱHaemolytic streptococcus

ISSN: 1741-7015