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A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia

ConditionsHospital-acquired Bacterial Pneumonia (HABP)Ventilator-associated Bacterial Pneumonia (VABP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol.

Male and female, ≥18 years.

Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.

All subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia.

Disqualifiers

Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.

Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.

HABP or VABP caused by obstruction.

Subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-8427

    Drug

    HRS-8427 for injection.

  • Meropenem

    Drug

    Meropenem for injection.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HRS-8427Experimental treatment 1 intervention
Group B: MeropenemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The all-cause mortality rate at Day 14.

Time frame
From the first dose of the study drug to Day 14.

Secondary outcomes

1

The all-cause mortality rate at Day 28.

Time frame
From the first dose of the study drug to Day 28.
2

The total ventilation time.

Time frame
Day 14 to Day 21.
3

The total ventilation time.

Time frame
Day 21 to Day 28.
4

The percentage of participants with microbiologic eradication at the early assessment (EA) period.

Time frame
Day 4 after the start of the treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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