A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study

Table 1 Study visits and reasons for early discontinuation of study medication

	Telavancin	Standard therapy	Overall
	(n = 29)	(n = 29)	(n = 58)
Completed FU visit	23 (79%)	26 (90%)	49 (84%)
Completed TOC visit	14 (48%)	17 (59%)	31 (53%)
Completed 14 days of therapy	13 (45%)	17 (59%)	30 (52%)
Discontinued study drugs early	16 (55%) ^a	12 (41%)	28 (48%)
Reason for early study drug discontinuation
Continuation criteria not met^b	5 (17%)	2 (7%)	7 (12%)
Adverse event	2 (7%)	2 (7%)	4 (7%)
Consent withdrawal	2 (7%)	2 (7%)	4 (7%)
2 Consecutive ECGs with QTc >500 msec	0	1 (3%)	1 (2%)
Major protocol deviation	1 (3%) ^c	0	1 (2%)
Other	6 (21%)	5 (17%)^d	11 (19%)

AE, adverse event; ECG, electrocardiogram; FU, follow-up visit; TOC, test-of-cure visit.
^aIncludes the only patient who was included under the amendment for complicated bacteremia and who was discontinued due to an AE after receiving 24 days of therapy.
^bA patient may have failed more than one continuation criterion; in patients failing continuation criteria the reason for early drug discontinuation decided by the investigators may have been different from not meeting such continuation criteria.
^cThis patient also failed continuation criteria.
^dOne patient in this group also failed continuation criteria.

ISSN: 1471-2334