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

NCT ID: NCT03978559

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2022-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumocystis Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAS with TMP/SMZ

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days

TMP/SMZ(trimethoprim/sulfisoxazole)

Intervention Type DRUG

TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days

Methylprednisolone

Intervention Type DRUG

40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days

TMP/SMZ

Group Type ACTIVE_COMPARATOR

TMP/SMZ(trimethoprim/sulfisoxazole)

Intervention Type DRUG

TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days

Methylprednisolone

Intervention Type DRUG

40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days

Interventions

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caspofungin

caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days

Intervention Type DRUG

TMP/SMZ(trimethoprim/sulfisoxazole)

TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days

Intervention Type DRUG

Methylprednisolone

40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days

Intervention Type DRUG

Eligibility Criteria

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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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bin Du

OTHER

Sponsor Role lead

Responsible Party

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Bin Du

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MICU of Peking Union Medical College

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Du

Role: CONTACT

0086-10-69155036

JINMIN PENG

Role: CONTACT

0086-10-69154040

Facility Contacts

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Bin Du, Dr

Role: primary

(8610)69155036

Other Identifiers

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MICU-PCP

Identifier Type: -

Identifier Source: org_study_id

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