Viral PneumoniaPhase 4PTHNCT02152358
PTH - Preemptive Treatment for Herpesviridae
A Phase 4 study testing Aciclovir and Ganciclovir in people with Viral Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Pneumonia
- What is being tested?
- Aciclovir and Ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2014to 5 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial
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.
- Conditions
- Viral Pneumonia
- Being tested
- Aciclovir, Ganciclovir, Placebo
- Keywords
- Cytomegalovirus, Herpes simplex virus, ICU, mechanical ventilation, mortality, ventilator-free days, PCR
- Medical subject headings
- Pneumonia, Viral, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AciclovirDrug
Intravenous 15 mg/kg/d during 14 days
GanciclovirDrug
intravenous 10 mg/kg/d for 14 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ganciclovir | Active comparator | Patients with a positive CMV PCR Receives: Drug: Ganciclovir |
| Ganciclovir placebo | Placebo comparator | Patients with a positive CMV PCR Receives: Drug: Placebo |
| Aciclovir | Active comparator | Patients with a PCR positive for HSV Receives: Drug: Aciclovir |
| Aciclovir placebo | Placebo comparator | Patients with a positive PCR for HSV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days at Day 60
Measured: 60 days
Secondary outcomes (15)
Day 60 mortality
Measured: 60 days
ICU mortality
Measured: 60 days
Hospital mortality
Measured: 60 days
Duration of mechanical ventilation in survivors
Measured: 60 days
Duration of ICU stay
Measured: 60 days
Duration of hospital stay
Measured: 60 days
Incidence of ventilator-associated pneumonia
Measured: 60 days
Incidence of bacteremia
Measured: 60 days
SOFA score
Measured: days 3, 5, 7, 14, 21 and 28
Acute renal failure related to aciclovir or its placebo
Measured: 60 days
Leucopenia related to ganciclovir or its placebo
Measured: 60 days
Time to oropharyngeal negativation of HSV PCR
Measured: 30 days
Time to blood negativation of CMV PCR
Measured: 30 days
Incidence of herpetic bronchopneumonia
Measured: 60 days
Incidence of active CMV infection
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start5 Feb 2014
- Primary completion21 Apr 2018
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Papazian, MD, PhD, Principal investigator, APHM - AMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152358
- Sponsor's protocol ID
- 20126003312-30
- Other IDs
- 2012-003312-30
- Acronym
- PTH
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2014
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31841577
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial
- ClinicalTrials.gov ID
- NCT02152358
- Acronym / sponsor ID
- PTH / 20126003312-30
- Conditions
- Viral Pneumonia
- Keywords
- Cytomegalovirus, Herpes simplex virus, ICU, mechanical ventilation, mortality, ventilator-free days, PCR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ganciclovir | Active comparator | Drug: GanciclovirPatients with a positive CMV PCR |
| Ganciclovir placebo | Placebo comparator | Drug: PlaceboPatients with a positive CMV PCR |
| Aciclovir | Active comparator | Drug: AciclovirPatients with a PCR positive for HSV |
| Aciclovir placebo | Placebo comparator | Drug: PlaceboPatients with a positive PCR for HSV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AciclovirIntravenous 15 mg/kg/d during 14 days | Drug | Aciclovir |
| Ganciclovirintravenous 10 mg/kg/d for 14 days | Drug | Ganciclovir |
| Placebo | Drug | Aciclovir placebo, Ganciclovir placebo |
Primary outcome
Ventilator-free days at Day 60
Time frame: 60 days
15 secondary outcomes
Day 60 mortality
Time frame: 60 days
ICU mortality
Time frame: 60 days
Hospital mortality
Time frame: 60 days
Duration of mechanical ventilation in survivors
Time frame: 60 days
Duration of ICU stay
Time frame: 60 days
Duration of hospital stay
Time frame: 60 days
Incidence of ventilator-associated pneumonia
Time frame: 60 days
Incidence of bacteremia
Time frame: 60 days
SOFA score
Time frame: days 3, 5, 7, 14, 21 and 28
Acute renal failure related to aciclovir or its placebo
Time frame: 60 days
Leucopenia related to ganciclovir or its placebo
Time frame: 60 days
Time to oropharyngeal negativation of HSV PCR
Time frame: 30 days
Time to blood negativation of CMV PCR
Time frame: 30 days
Incidence of herpetic bronchopneumonia
Time frame: 60 days
Incidence of active CMV infection
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 31841577Luyt 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Papazian, MD, PhD principal investigator
APHM - AMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aciclovir and Ganciclovir in people with Viral Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days at Day 60 (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.