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PneumocystisPhase 3PICNCT02944045

Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

A Phase 3 study testing Methylprednisolone in people with Pneumocystis and Steroids, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumocystis, Steroids, Immunocompromised Patient
What is being tested?
Methylprednisolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
1 siteFrance
Study dates
15 Feb 2017to Oct 2022
Phase
Phase 3
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

  • Age ≥ 18 years
  • Severe PcP : 1 / interstitial acute pneumonia with possible or typical criteria for PcP and positive specimen for Pneumocystis jirovecii (excluding PCR) ; or interstitial acute pneumonia with typical criteria for PcP and positive PCR in respiratory specimen. 2/ Arterial pression of Oxygen (PaO2) < 60 mmHg on room air need of 3 L/min oxygen for saturation >92% or tachypnea>30min need of mechanical ventilation for acute respiratory failure.
  • Treatment for PcP started for less than 7 days.
  • Non-HIV immunosuppression : malignant hematological disease, solid tumor cured for less than 5 years, allogenic stem cell transplant, Steroids (>0.3mg/kg equivalent prednisone for more than 3 weeks or > 20mg/days for more than one months) or other immunosuppressive treatment for more than one months or solid organ transplantation.
  • Signed inform consent by patient or relatives
  • Health insurance

Who cannot join

  • HIV Serology HIV 1 or 2 positive
  • Need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute Graft versus Host disease (GVH= for example)
  • Contra-indication for steroids
  • Pregnancy of breath-feeding
  • Denied to participate
  • No health insurance
  • tutelage

Trial locations and contacts

1 site in 1 country.

Virginie Lemiale, MD contact

142499419 ext. +33

virginie.lemiale@aphp.fr

Matthieu Resche-Rigon, MD PHD contact

142499742 ext. +33

matthieu.resche-rigon@univ-paris-diderot.fr

France1 site, 1 recruiting

  • Medical ICU

    Paris, 75010

    virginie lemiale, MD, 142499419 ext. +33, virginie.lemiale@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC

Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids remains controversy. Some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies were retrospective, non randomised studies including various underlying disease and severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult to interpret all the results.

The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.

Being tested
Methylprednisolone, Placebo
Medical subject headings
Pneumonia, Pneumocystis, Hematologic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    Methylprednisolone intra veinous

    • Day 1 to 5 : 30mg twice per day
    • Day 6 to 10 : 30mg per day
    • Day 11 to 21 : 20mg per day

  • PlaceboDrug

    saline serum

Study groups in NCT02944045
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSaline serum, same volume as in the Experimental arm.
Receives: Drug: Placebo
SteroidsExperimentalMethylprednisolone intra veinous * Day 1 to 5 : 30mg twice per day * Day 6 to 10 : 30mg per day * Day 11 to 21 : 20mg per day
Receives: Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    28 days mortality after the randomisation

    Measured: Day 28

Secondary outcomes (11)

  1. Mortality

    90 days mortality after the randomisation

    Measured: Day 90

  2. Hospital mortality

    Mortality at hospital discharge

    Measured: Day 120

  3. ICU mortality

    For patients admitted to ICU at ICU discharge

    Measured: Day 90

  4. Acute respiratory failure

    Acute respiratory failure during treatment defined by one of those criteria within 28 days :

    • Increased need of oxygen (more than 9 l/min of high flow nasal oxygen with Inspired Fraction of Oxygen (fiO2) >50%)
    • Admission to ICU after randomisation
    • Need of mechanical ventilation (invasive or non invasive) or high flow nasal oxygen

    Measured: Day 28

  5. Duration of mechanical ventilation

    Duration of mechanical ventilation invasive and/or non invasive

    Measured: Day 28

  6. Occurrence of septic shock

    septic shock is defined as need for vasopressor

    Measured: Day 28

  7. acute kidney injury

    KDIGO score >=1

    Measured: Day 28

  8. Hospital acquired infectious disease

    Global incidence incidence of infections. Incidence of pulmonary or extra-pulmonary infections.

    Incidence of bacterial, viral and fungal infections. Diagnosis of infectious disease will be defined by the need of treatment.

    Measured: Day 28

  9. Hospital length of stay

    Hospital length of stay at hospital discharge

    Measured: Day 120

  10. ICU length of stay

    ICU length of stay at ICU discharge

    Measured: Day 90

  11. Duration of Insulin treatment

    Insulin treatment is defined :

    • patient without insulin treatment before study : start of insulin therapy
    • patient treated with insulin before study : increased dose (>30%) of insulin

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944045
Sponsor's protocol ID
P150961
Other IDs
2016-002275-10, 2016
Acronym
PIC
Status last verified
Oct 2020
First submitted
17 Oct 2016
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rosales-Chavez G, Martinez-Ayala P, Ambriz-Alarcon MA, Rubio-Mora BR, Arcos-Jimenez JC, Lopez-Yanez AM, Marin-Castaneda-Baron A, Briseno-Hernandez AA, Villafan-Bernal JR, Sanchez-Gutierrez JA, Briseno-Ramirez J. Adjunctive corticosteroids in non-HIV immunocompromised patients with Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Ther Adv Infect Dis. 2026 Aug 4;13:20499361261468451. doi: 10.1177/20499361261468451. eCollection 2026 Jan-Dec.

    PubMed 42558999

  • Lemiale V, Resche-Rigon M, Zerbib Y, Mokart D, De Prost N, Wallet F, Perez P, Kouatchet A, Argaud L, Decavele M, Pene F, Seguin A, Megarbane B, Calvet L, Picard M, Rigault G, Mariotte E, Bouadma L, Theodose I, Tamion F, Klouche K, Colin G, Nyunga M, Moreau AS, Azoulay E. Adjunctive corticosteroids in non-AIDS patients with severe Pneumocystis jirovecii pneumonia (PIC): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2025 Sep;13(9):800-808. doi: 10.1016/S2213-2600(25)00125-0. Epub 2025 Jul 10.

    PubMed 40652952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylprednisolone in people with Pneumocystis and Steroids, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Virginie Lemiale, MD (142499419 ext. +33, virginie.lemiale@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Day 28). 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 NCT02944045, which also lists 2 linked publications.

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 Oct 2020.

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