Actively Recruiting

Age: 18Years - 60Years
All Genders
ID06691321

Efficacy of Caspofungin for Pneumocystis Jirovecii Pneumonia in People Living With HIV/AIDS.

Led by Instituto Nacional de Enfermedades Respiratorias · Updated on 2024-11-19

60

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pneumocystis jirovecii pneumonia (PCP) is a serious infection affecting people living with HIV/AIDS and can be severe or even fatal. The standard treatment has been trimethoprim/sulfamethoxazole for over thirty years, but safety concerns exist with alternative second-line drugs. Research has focused on the beta-D glucan in Pneumocystis jirovecii, leading to interest in echinocandins like caspofungin, which have shown promise in animal studies and some positive human observations. This observational study compares the use of caspofungin with the standard treatment of trimethoprim/sulfamethoxazole for PCP in people living with HIV. One group receives the standard drug, while the other receives caspofungin alone or with clindamycin or primaquine, including patients who switch to caspofungin early in treatment. The study aims to assess caspofungin's safety and effectiveness as an alternative with a better safety profile. Participants will be monitored up to 90 days to evaluate outcomes such as mortality at 30 and 90 days, length of hospital stay, need for advanced respiratory support, incidence of respiratory distress, and any adverse events. Clinical and laboratory studies will be done at admission, and data will be collected to compare the treatments. The study is sponsored by the Instituto Nacional de Enfermedades Respiratorias and runs until September 2025.

CONDITIONS

Brief Title

Caspofungin for Pneumocystis Pneumonia in PLWHIV.

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of probable or proven Pneumocystis jirovecii pneumonia (PCP) according to established classification criteria.
  • Availability of clinical, laboratory, and virological diagnostic studies at the time of admission.
Not Eligible

You will not qualify if you...

  • Switching to caspofungin treatment after day 7 of initial treatment.
  • Development of an additional opportunistic lung infection during hospitalization, except cytomegalovirus pneumonitis or SARS-CoV-2 pneumonia.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 90 days

Participants with HIV and Pneumocystis jirovecii pneumonia are observed during treatment with either trimethoprim/sulfamethoxazole or caspofungin.

Follow-up visits up to 90 days after treatment initiation

Trial Site Locations

Total: 1 location

1

Center for Research in Infectious Diseases (CIENI)

Mexico City, Tlalpan, Mexico, 14080

Actively Recruiting

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Research Team

X

Xavier Flores, MD

X

Xavier Flores, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Diagnosis of Pneumocystis jirovecii pneumonia in immunocompromised patients by real-time PCR: a 4-year prospective study.

Florence Robert-Gangneux, Sorya Belaz, Matthieu Revest...

https://pubmed.ncbi.nlm.nih.gov/25009050

Caspofungin combined with TMP/SMZ as a first-line therapy for moderate-to-severe PCP in patients with human immunodeficiency virus infection.

Q Tian, J Si, F Jiang...

https://pubmed.ncbi.nlm.nih.gov/33277811

No Statistically Apparent Difference in Antifungal Effectiveness Observed Among Trimethoprim/Sulfamethoxazole Plus Clindamycin or Caspofungin, and Trimethoprim/Sulfamethoxazole Monotherapy in HIV-Infected Patients with Moderate to Severe Pneumocystis Pneumonia: Results of an Observational Multicenter Cohort Study.

Yinqiu Huang, Xiaoqing He, Hui Chen...

https://pubmed.ncbi.nlm.nih.gov/35050490

Echinocandin treatment of pneumocystis pneumonia in rodent models depletes cysts leaving trophic burdens that cannot transmit the infection.

Melanie T Cushion, Michael J Linke, Alan Ashbaugh...

https://pubmed.ncbi.nlm.nih.gov/20126455

Therapeutic potential of caspofungin combined with trimethoprim-sulfamethoxazole for pneumocystis pneumonia: a pilot study in mice.

Maria Luísa Lobo, Francisco Esteves, Bruno de Sousa...

https://pubmed.ncbi.nlm.nih.gov/23940606