Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP

Bin Du

Status and phase: Unknown; Phase 4

Conditions: Pneumocystis Pneumonia

Treatments: Drug: caspofungin; Drug: Methylprednisolone; Drug: TMP/SMZ(trimethoprim/sulfisoxazole)

Study type: Interventional

Funder types: Other

Identifiers

NCT03978559

MICU-PCP

Details and patient eligibility

About

This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.

The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. Non-HIV immunosuppressed patients admitted to the ICU
3. confirmed or suspect PCP

3. Not receiving anti-PCP treatment or anti-PCP treatment < 48 hours

Exclusion criteria

1. Age less than 18 years old
2. Known pregnancy
3. allergy to TMP/SMZ or caspofungin
4. Decision to withhold life-sustaining treatment
5. Patients with advanced pulmonary fibrosis
6. severe liver dysfunction(Child-Pugh C )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

CAS with TMP/SMZ

Experimental group

Treatment:

Drug: caspofungin

Drug: Methylprednisolone

Drug: TMP/SMZ(trimethoprim/sulfisoxazole)

TMP/SMZ

Active Comparator group

Treatment:

Drug: Methylprednisolone

Drug: TMP/SMZ(trimethoprim/sulfisoxazole)