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CompletedNCT04066621CRO-SBTUpdated Aug 28, 2019

PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)

A Phase 4 interventional study of Ceftriaxone Sodium and Sulbactam Sodium for Injection in Respiratory Tract Infections and Urinary Tract Infections in Children, sponsored by Xiangbei Welman Pharmaceutical Co., Ltd. Completed. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Xiangbei Welman Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Apr 2015, registered Aug 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
6 Years to 14 Years
Sex
All
01

Study summary

To evaluate the safety and efficacy of treatment of children with acute bacterial infection disease with Ceftriaxone Sodium and Sulbactam Sodium for Injection in the condition of widely used, and provide the basis of adjusting the dosage regimen for children in particular.

Read the detailed description

Ceftriaxone sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis,the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Ceftriaxone can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Ceftriaxone in the treatment-resistant pathogen infections.

02

Conditions studied

  • Respiratory Tract Infections
  • Urinary Tract Infections in Children
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 30 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Xiangbei Welman Pharmaceutical Co., Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female children ages≥6 years to\< 14 years.
  • Weight≥18kg who in hospital or outpatients with good compliance;
  • The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics;
  • Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious;
  • No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range);
  • Subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent.

Exclusion criteria

Exclusion Criteria:

  • History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics;
  • Patients with specific infections who require treatment with other antimicrobial agents;
  • Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time;
  • Patients at risk of serious drug interactions due to combination of medications;
  • Patients who have other diseases and thought to affect efficacy evaluations or be poor compliance;
  • Attended clinical trial in three monthes.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CRO-SBT

    Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)

    Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection

Interventions

  • DrugCeftriaxone Sodium and Sulbactam Sodium for Injection

    daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days

    Also known as: weipufen

06

What researchers measure

Primary outcomes

  1. The cure rate of patients

    Clinically effective/Clinically ineffective

    Time frame: Seven days after treatment

Secondary outcomes

  1. bacterial clearance rate

    end of treatment of bacteriological efficacy (bacterial clearance rate)

    Time frame: 48 hours after treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04066621
Lead sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Aug 26, 2019
Start date
Apr 28, 2015
Primary completion
Jun 11, 2016
Completion
May 27, 2017
Last update
Aug 28, 2019

Study contacts

yuhua hu, Doctor
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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