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NCT03731156: NC
Granulomatous Pneumocystis Pneumonia
trial in Pulmonary Nodule in 16 participants. Completed in 30 December 2019.
30 December 2019
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 16 |
| Start date | 1 June 2018 |
| Primary completion | 30 December 2019 |
| Estimated completion | 30 December 2019 |
| Sites | 1 location across France |
Conditions studied
- Pulmonary Nodule — all drugs for Pulmonary Nodule →
- Invasive Fungal Infections — all drugs for Invasive Fungal Infections →
- Pneumocystis Jirovecii — all drugs for Pneumocystis Jirovecii →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Pulmonary Nodule or Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The intra-alveolar form of Pneumocystis jiroveci pneumonia (PjP) is a common pathology in immunocompromised patients, particularly those infected with HIV. The diagnosis is based on the detection of Pj in a LBA. Intra-tissue granulomatous form (PGP) is a rare entity observed in non-HIV immunocompromised patients. In this case, the LBA is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. For many years, it has been clearly demonstrated that the use of a specific PCR clearly improves the biological diagnosis of PcP. However, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned. In 2018, two cases of PGP were diagnosed at 3-month intervals at Montpellier University Hospital Center. The diagnostic confirmation was obtained with PCR Pj. In this context the investigators will investigate the interest of implementing PCR Pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. In all selected patients, histopathological aspect of the nodule was compatible with a PGP and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). Finally, 17 patients were selected to check retrospectively, if the presence of Pj could be at the origin of the pathology.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03731156
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03731156 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 10 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03731156.
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