Multicentric clinical trial on the efficacy and safety of ceftriaxone and sulbactam in lower respiratory tract infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51896330

Enrollment

105

Registered

2006-06-23

Start date

2005-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower respiratory tract infection Infections and Infestations Respiratory tract infection

Interventions

Treatment consisted of 1 g ceftriaxone + 0.5 g sulbactam in intravenous fixed dose combination every eight hours for 7 -10 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Fever =38°C 3. Sputum pus cells >25 high power fields (HPF) 4. Buccal epithelial cells <10 HPF

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to ceftriaxone, sulbactam or related drugs 2. Children less than 18 years of age 3. Septicemic shock, active pulmonary malignancies, renal and hepatic insufficiencies

Design outcomes

Primary

Measure	Time frame
The overall efficacy of fixed dose combination (FDC) of ceftriaxone and sulbactam was excellent. The clinical cure rate was 77.14% and the bacteriological cure rate was 100%. A total of three adverse reactions were noted in 12 of the 105 patients receiving ceftriaxone and sulbactam (FDC) but none of them warranted discontinuation of treatment. Adverse effects noted included: pain at the injection site (5.7%), superficial thrombophlebitis (4.76%), and mild diarrhea (0.95%).	—

Measure

Time frame

The overall efficacy of fixed dose combination (FDC) of ceftriaxone and sulbactam was excellent. The clinical cure rate was 77.14% and the bacteriological cure rate was 100%. A total of three adverse reactions were noted in 12 of the 105 patients receiving ceftriaxone and sulbactam (FDC) but none of them warranted discontinuation of treatment. Adverse effects noted included: pain at the injection site (5.7%), superficial thrombophlebitis (4.76%), and mild diarrhea (0.95%).

—

Secondary

Measure	Time frame
Ceftriaxone and sulbactam in fixed dose combination (FDC) is an effective and well-tolerated antimicrobial agent that appears promising for the treatment of serious lower respiratory tract infections	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026