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Trial record 2 of 5 for:    "Lung Disease" | "Caspofungin"

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

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ClinicalTrials.gov Identifier: NCT03978559
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bin Du, Peking Union Medical College Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pneumocystis Pneumonia Drug: caspofungin Drug: TMP/SMZ(trimethoprim/sulfisoxazole) Drug: Methylprednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : July 8, 2022


Arm Intervention/treatment
Experimental: CAS with TMP/SMZ Drug: caspofungin
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days

Drug: TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days

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

Active Comparator: TMP/SMZ Drug: TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days

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




Primary Outcome Measures :
  1. mortality to day 28 [ Time Frame: 28 days after randomization ]
    The percentage of subjects death at study day 28. Those subjects discharged from ICU prior to day 28 were counted as alive at day 28


Secondary Outcome Measures :
  1. ICU Free Days to day 28 [ Time Frame: 28 days after randomization ]
    defined as the number of days between randomization and day 28 in which the patient is not in the ICU (for any part of a day)

  2. Mean Ventilator Free Days to day 28 [ Time Frame: 28 days after randomization ]
    Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

  3. ICU mortality [ Time Frame: through ICU discharge, an average of 14 days ]
    The percentage of death subjects at ICU discharge

  4. hospital mortality [ Time Frame: through hospital discharge, an average of 28 days ]
    The percentage of death subjects at hospital discharge

  5. PO2/FiO2 on day 7, 21 [ Time Frame: day 7, 21 after randomization ]
    the change of PO2/FiO2 between baseline and day7, 21

  6. serum (1,3)-β-D gluca level on day 3, 7, 21 [ Time Frame: day3, 7, 21 after randomization ]
    the change of (1,3)-β-D glucan level between baseline and day3, 7, 21

  7. PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization [ Time Frame: day 7 after randomization ]
    the percentage of PCP-DNA negative after 7days treatment

  8. SOFA [ Time Frame: day3, 7, 21 after randomization ]
    respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system

  9. BALF cytokines level on day3, 7, 21 [ Time Frame: day3, 7, 21 after randomization ]
    the change of cytokines in bronchoalveolar lavage fluid (BALF) level between baseline and day7, day21

  10. adverse events [ Time Frame: till 21 days after randomization ]
    incidence, duration and severity of adverse events

  11. serious adverse events [ Time Frame: till 21 days after randomization ]
    incidence, duration and severity of serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978559


Contacts
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Contact: Bin Du 0086-10-69155036 dubin98@gmail.com
Contact: JINMIN PENG 0086-10-69154040 pjm731@hotmail.com

Locations
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China
MICU of Peking Union Medical College Recruiting
Beijing, China, 100730
Contact: Bin Du, Dr    (8610)69155036    dubin98@gmail.com   
Sponsors and Collaborators
Bin Du

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Responsible Party: Bin Du, Director, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03978559     History of Changes
Other Study ID Numbers: MICU-PCP
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Fungal
Caspofungin
Pneumonia, Pneumocystis
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Mycoses
Pneumocystis Infections
Trimethoprim
Sulfamethoxazole
Sulfisoxazole
Methylprednisolone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents