Cytomegalovirus Control in Critical Care

Summary

The purpose of this study is to determine whether reactivation of latent cytomegalovirus infection in critically ill patients looked after in the intensive care unit can be successfully and safely prevented using antiviral agents. Comparison is made between standard care, and treatment with one of two different antiviral regimens: valaciclovir/aciclovir, which has a favourable side effect profile but requires high dosage to be effective, and valganciclovir/ganciclovir, which has more side effects, but has been demonstrated to be effective in low dosage. The primary hypothesis is that cytomegalovirus reactivation can be effectively suppressed with antiviral prophylaxis.

Timeline

Start

2012-01

Primary completion

2014-01

Completion

2014-03

Outcome

Met primary endpoint

paper 12 patients in the control group, compared with 1 patient in the valganciclovir group and 2 patients in the valacyclovir group PMID 28437539 ↗

paper combined treatment groups vs control: hazard ratio, 0.14; 95% CI 0.04-0.50 PMID 28437539 ↗

Publications

• Cowley NJ, Owen A, Shiels SC, Millar J, Woolley R, Ives N, Osman H, Moss P, Bion JF. Safety and Efficacy of Antiviral Therapy for Prevention of Cytomegalovirus Reactivation in Immunocompetent Critically Ill Patients: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jun 1;177(6):774-783. doi: 10.1001/jamainternmed.2017.0895.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acyclovir	Small molecule	10 mg/kg	Intravenous
Subject	Ganciclovir	Small molecule	2.5 mg/kg	Intravenous
Subject	Valaciclovir	Unknown	2 g	—
Subject	Valganciclovir	Small molecule	450 mg	—

Indications

No indication recorded.