PTH - Preemptive Treatment for Herpesviridae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-05

Study Completion Date

2023-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis

NCT04706507

Acute Respiratory Failure

TERMINATED PHASE3

Evaluation of the Pharmacokinetics (PK) and Pharmacodymamics (PD) of Ganciclovir (GCV) in Premature Infants Receiving Treatment for Cytomegalorivus (CMV) Infection

NCT01602614

Cytomegalovirus Infections

COMPLETED

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

NCT00002095

Cytomegalovirus Infections HIV Infections

COMPLETED NA

Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

NCT07235683

CMV Lung Transplant Recipient

NOT_YET_RECRUITING PHASE4

Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

NCT00002024

Cytomegalovirus Infections HIV Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Viral Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ganciclovir

Patients with a positive CMV PCR

Group Type ACTIVE_COMPARATOR

Ganciclovir

Intervention Type DRUG

intravenous 10 mg/kg/d for 14 days

Ganciclovir placebo

Patients with a positive CMV PCR

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Aciclovir

Patients with a PCR positive for HSV

Group Type ACTIVE_COMPARATOR

Aciclovir

Intervention Type DRUG

Intravenous 15 mg/kg/d during 14 days

Aciclovir placebo

Patients with a positive PCR for HSV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aciclovir

Intravenous 15 mg/kg/d during 14 days

Intervention Type DRUG

Ganciclovir

intravenous 10 mg/kg/d for 14 days

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* mechanical ventilation \> 96 hrs and expected duration of mechanical ventilation of at least 2 days
* positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR
* age \> 18 years
* informed consent
* negative pregnancy test

Exclusion Criteria

* \< 18 years
* Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV
* Had received antiviral agent active against HSV/CMV during the previous month
* Hypersensitivity to aciclovir/ganciclovir
* Pregnancy
* Breast feeding
* Bone marrow failure
* Solid organ recipients
* Bone marrow recipients
* HIV positive patients
* Receiving immunosuppressive agents
* SAPS II \> 75
* Withdrawing/withholding
* Neutropenia (\< 500 mm3)
* Thrombocytopenia (\< 25 G/L)
* ICU readmission

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No