TABLE 11.

Randomized clinical trials (RCTs) for treatment of ventilator-associated pneumonia (VAP)

Reference	Regimen	Population	Disease severity	Setting	Response	Comments
265	Cefotaxime (CFT) 2 g q8h IV versus ceftriaxone (CRX) 2 g q24h IV	>18 years old	Moderate-severe	ICU	Clinical response at end of therapy	Open label RCT
		MV 90%		(CFT) n=26	(CFT) 73%
				(CRX) n=25	(CRX) 48%, P=0.04
379	Ceftazidime (CTZ1) 1 g q8h IV versus ceftazidime (CTZ2) 2 g q8h IV	Adults	Moderate-severe	ICU	Clinical response at end of therapy	Single-blind RCT
		MV 72% (CTZ1)		(CTZ1) n=25	(CTZ1) 80%
		MV 92% (CTZ2)		(CTZ2) n=25	(CTZ2) 92%
60	Imipenem (I) 1 g q8h IV versus ciprofloxacin (CIP) 400 mg q8h IV	>18 years old	Moderate-severe	ICU	Primary end point bacteriological response 3–7 d post Rx	Double-blind RCT
		78% (I)-HAP		(I) n=76	(I) 58%
		78% (CIP)-HAP		(CIP) n=83	(CIP) 69%
		MV 80.6% (CIP)
		MV 76.9% (I)
151	Piperacillin/tazobactam (P/T) 4.5 g QID IV or CTZ 1 g QID IV with amikacin 7.5 mg/kg BID IV	Adults	Moderate-severe	ICU	Clinical response 6–8 d post-therapy	Open label RCT
		MV 100% (P/T)		(P/T) n=51	(P/T) 51%
		MV 100% (CTZ)		(CTZ) n=64	(CTZ) 36%
85	CIP 800–1200 mg IV/d versus I 2–4 g IV/d	>18 years old	Moderate-severe	ICU	Clinical response	Open label RCT
		MV 100% (CIP)		(CIP) n=41	(CIP) 71%
		MV 100% (I)		(I) n=34	(I) 79%
					P aeruginosa
					(CIP) 71%
					(I) 67%
47	P/T 4.5 g q6h IV or CTZ 2 g q8h IV with amikacin (A) 7.5 mg/kg q12h IV	>18 years old	Moderate-severe	ICU	Clinical response at end of treatment	Open label RCT
		MV 100% (P/T)		(P/T) n=83	(P/T) 63.9%
		MV 100% (CTZ+A)		(CTZ+A) n=26	(CTZ+A) 61.5%
380	CTZ-CI (continuous infusion) 3 g/d or CTZ-II 2 g q8h IV plus tobramycin (T) 7 mg/kg QD IV	>18 years old	Moderate-severe	ICU	Clinical response 14–21 days post-therapy	Open label RCT
		MV 89% (CTZ-CI)		(CTZ-II) n=17	(CTZ-CI) 83%
		MV 94% (CTZ-II)		(CTZ-II) n=18	(CTZ-II) 94%
266	Linezolid (L) 600 mg q12h IV or vancomycin (V) 1 g q12h IV with aztreonam 1–2 g q8h IV	>18 years old	Severe	ICU	ITT population clinical cure 12–28 d post-therapy	2 double-blind RCTs (L) versus (V) combined
		MV 100% (L)		(L) n=282
		MV 100% (V)		(V) n=262
				S aureus	S aureus
				(L) n=88	(L) 48.9%
				(V) n=91	(V) 35.2%, P=0.06
				MRSA	MRSA
				(L) n=37	(L) 62.2%
				(V) n=33	(V) 21.2%, P=0.001
381	Levofloxacin (LFX) 750 mg q24h IV versus I 500–1000 mg q6–8h IV	Adults	Moderate-severe	ICU	Response in clinically evaluable	Open label RCT
		MV 100% (LFX)		(LFX) n=111	(LFX) 56.1%
		MV 100% (I)		(I) n=111	(I) 58.1%

Mechanical ventilation (MV) >75% = VAP; MV 50% to 75%= hospital-acquired pneumonia (HAP)/VAP; MV <50% = HAP. BID Twice daily; d Day; ICU Intensive care unit; ITT Intention to treat; IV Intravenous; MRSA Methicillin-resistant Staphylococcus aureus; NA Not Available; P aeruginosa Pseudomonas aeruginosa; q Every; QD Daily; QID Four times daily; Rx Treatment