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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003312-30 | EudraCT Number |
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The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganciclovir | Active Comparator | Patients with a positive CMV PCR |
|
| Ganciclovir placebo | Placebo Comparator | Patients with a positive CMV PCR |
|
| Aciclovir | Active Comparator | Patients with a PCR positive for HSV |
|
| Aciclovir placebo | Placebo Comparator | Patients with a positive PCR for HSV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aciclovir | Drug | Intravenous 15 mg/kg/d during 14 days |
| |
| Ganciclovir |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days at Day 60 | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Day 60 mortality | 60 days | |
| ICU mortality | 60 days | |
| Hospital mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Papazian, MD, PhD | APHM - AMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Marseille | Marseille | 13015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31841577 | Derived | Luyt CE, Forel JM, Hajage D, Jaber S, Cayot-Constantin S, Rimmele T, Coupez E, Lu Q, Diallo MH, Penot-Ragon C, Clavel M, Schwebel C, Timsit JF, Bedos JP, Hauw-Berlemont C, Bourenne J, Mayaux J, Lefrant JY, Mira JP, Combes A, Wolff M, Chastre J, Papazian L; Preemptive Treatment for Herpesviridae Study Group, Reseau Europeen de recherche en Ventilation Artificielle Network. Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):263-272. doi: 10.1001/jamainternmed.2019.5713. |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Drug |
intravenous 10 mg/kg/d for 14 days |
|
| Placebo | Drug |
|
| 60 days |
| Duration of mechanical ventilation in survivors | 60 days |
| Duration of ICU stay | 60 days |
| Duration of hospital stay | 60 days |
| Incidence of ventilator-associated pneumonia | 60 days |
| Incidence of bacteremia | 60 days |
| SOFA score | days 3, 5, 7, 14, 21 and 28 |
| Acute renal failure related to aciclovir or its placebo | 60 days |
| Leucopenia related to ganciclovir or its placebo | 60 days |
| Time to oropharyngeal negativation of HSV PCR | 30 days |
| Time to blood negativation of CMV PCR | 30 days |
| Incidence of herpetic bronchopneumonia | 60 days |
| Incidence of active CMV infection | 60 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |