Center for Research in Infectious Diseases (CIENI)
Mexico City, Tlalpan, 14080, Mexico
Location status: Recruiting
Location contact
Xavier Flores, MD
CONTACT
(+52 55) 5940 2110
Xavier Flores, MD
CONTACT
(+52 55) 5666 7985 ext. 164
NCT Number: NCT06691321
Pneumocystis jirovecii pneumonia is a significant concern in peaple with HIV/AIDS, often severe and potentially fatal. While trimethoprim/sulfamethoxazole remains the primary treatment, safety concerns exist with alternative options. Research on Pneumocystis jirovecii's beta-D glucan composition has prompted investigations into echinocandins like caspofungin, showing promise in murine models and some positive results in human studies. Evaluating caspofungin's efficacy through observational studies is crucial due to safety advantages over current treatments and limited documented data.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Mexico City, Tlalpan, 14080, Mexico
Location status: Recruiting
Xavier Flores, MD
CONTACT
(+52 55) 5940 2110
Xavier Flores, MD
CONTACT
(+52 55) 5666 7985 ext. 164
Pneumocystis jirovecii pneumonia (PCP) is a significant opportunistic disease in immunocompromised patients with HIV/AIDS, becoming increasingly prevalent. This condition can range in severity, at times being fatal and necessitating drastic measures. The standard first-line treatment, trimethoprim/sulfamethoxazole, has been unchanged for over three decades. While other drugs have been approved as second-line treatments, they come with safety concerns such as increased risk of hypersensitivity reactions and adverse effects.
Research on Pneumocystis jirovecii has faced challenges due to difficulties in cultivation, requiring in vivo models for study. Previous studies have found that the wall of Pneumocystis spp. contains beta-D glucans in one phase of its life cycle. This discovery has led to investigations into the effectiveness of echinocandins, specifically caspofungin, on Pneumocystis spp. Promising results have been observed in murine models; however, these studies were conducted on species that do not affect humans. Clinical observational studies in humans have shown positive response and safety, albeit using caspofungin in combination with other drugs rather than as monotherapy.
Considering the superior safety profile of echinocandins compared to first-line treatments for P. jirovecii, and the limited documented data in case reports or series, it is important to assess the efficacy of caspofungin in observational studies to address this gap.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Proven: Confirmation by pathology or microbiology. Possible: Presence of three out of four clinical or radiological criteria. Probable: Presence of one clinical or radiological criterion without another identified microorganism.
Exclusion criteria
Time frame: 30 days
Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 30-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
Time frame: 90 days
Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 90-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
Time frame: 90 days
Compare the length of hospital stay between the groups.
Time frame: 90 days
Compare the requirement and duration of high-flow nasal cannula between the groups.
Time frame: 90 days
Compare the requirement and duration of invasive mechanical ventilation between the groups.
Time frame: 90 days
Compare the incidence of acute respiratory distress syndrome during hospitalization.
Time frame: 90 days
Determine the incidence of adverse reactions to the different regimens used as treatment for PCP.
Contact information is provided by the study sponsor or research team.
Xavier Flores, MD
CONTACT
(+52 55) 5940 2110
Xavier Flores, MD
CONTACT
(+52 55) 5666 7985 ext. 164
Instituto Nacional de Enfermedades Respiratorias
Other Gov
Efficacy of Caspofungin for Pneumocystis Jirovecii Pneumonia in People Living With HIV/AIDS.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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