Condition category
Infections and Infestations
Date applied
25/05/2007
Date assigned
27/06/2007
Last edited
27/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pawanindra Lal

ORCID ID

Contact details

Maulana Azad Medical College and Hospital
New Delhi
100012
India
+91 989 1209609
drplal@bol.net.in

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT/RX-PHARM/07

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy and safety of ceftriaxone and sulbactam combination in patients with skin and soft tissue infections.

Ethics approval

Dhanavantri Independent Ethics Committee (New Delhi), approved on 14th May 2007.

Study design

An open, parallel, randomised, prospective, comparative trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Skin and soft tissue infections

Intervention

Intervention group: Ceftriaxone (1 gram) and sulbactam (0.5 gram) every 12 hours for maximum of 7 days
Control group: Ceftriaxone (1 gram) every 12 hours for maximum of 7 days

Intervention type

Drug

Phase

Not Specified

Drug names

ceftriaxone and sulbactam

Primary outcome measures

Clinical cure:
The criterion for the clinical cure requires total resolution of all signs and symptoms of the infection associated with complete healing of lesions (i.e. lesions disappear or are completely dry), or improvement of the above to such an extent that no further antimicrobial therapy is necessary, as assessed at the end of therapy. Clinical assessments will be carried out four times during the trial period: on admission into the study (Day 1), therapy assessment on Day 3 and Day 5, and end of therapy at Day 7.

The following sings and symptoms are examined during follow up visits for clinical response:
1. Fever
2. Chills
3. Malaise
4. Number of lesions
5. Length and width of largest lesion
6. Pain at the site of lesion
7. Ulceration of lesion
8. Type of discharge
9. Crust/scrub formation
10. Erythema around lesion
11. Warmth
12. Tenderness
13. Induration
14. Regional lymphadenopathy
15. New lesions

Secondary outcome measures

Bacteriological cure:
The secondary efficacy measure is microbiological outcome. To be considered microbiologically evaluable, patients should be clinically evaluable, have microbiological diagnosis based on isolation of a susceptible pathogen in the wound culture at study admission and should have end of therapy (Day 7) microbiological assessments. Microbiological outcome will be classified as follows:

Eradication: The absence of original pathogen(s) from post treatment wound culture performed at the end of therapy assessment.

Presumed Eradication: Presumed eradication of pathogen(s) isolated at study admission in the absence of a repeat wound culture due to inability to perform sampling at the end-of therapy assessment and definition of clinical cure/improvement is met.

Persistence: Lack of eradication of the original pathogen(s) isolated at the post treatment wound culture at the end of therapy assessments.

Presumed persistence: In a patient who is judged to be clinical failure, and wound culture is not possible or is not done, it is presumed that there is persistence of the pathogen.

Indeterminate: Wound culture was negative at study admission, or culture was not done at the end-of-therapy assessment even if the lesion has not healed at that assessment.

Super Infection: Isolation of a pathogen other than the original pathogen from post-treatment wound culture at the end-of therapy assessment.

Overall trial start date

15/05/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients aged >18 years
2. Diagnosis of skin and skin structure infections of sufficient severity and with signs of systemic illness requiring injectable antibiotics. The diagnosis of Skin and Soft Tissue Infections (SSTI) should be made on the basis of clinical and microbiological criteria as follows:
a. Infection that involves soft tissue (including deep and extensive cellulitis; abscesses, necrotizing fasciitis, surgical site infections; burns [<10% of total body surface area]) or
b. Requiring surgical interventions or
c. Associated with significant underlying disease/s such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy or venous insufficiency.
A surgical intervention is not necessary for entering this study, but it will be allowed at the start of the study.
3. At least two of the following signs and symptoms:
3.1. Drainage or discharge
3.2. Fever (oral temperature >38.50 °C or 101.40 °F)
3.3. Erythema
3.4. Swelling / fluctuation
3.5. Local warmth
3.6. Pain / tenderness
3.7. White Blood Cell (WBC) count of >10.0000 cells / mm3
4. Patients of SSTI requiring parenteral antibiotic administration for minimum of 5 days
5. All patient should have a microbiological specimen (culture material) obtained from skin lesions prior initiation of therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 completed cases will be evaluated (more participants may be recruited as some participants may not complete the intervenion / follow-up)

Participant exclusion criteria

1. Unwilling or unable to give informed consent
2. Female patients of childbearing potential who are not practicing a reliable form of contraception
3. Significant mental retardation
4. Less than 18 years old
5. Hypersensitivity to ceftriaxone, sulbactam or any other beta-lactam agents
6. Presenting with sustained shock (Systolic Blood Pressure (SBP) <90 mm Hg for 2 hours, despite adequate fluid resuscitation)
7. Concomitant infection that requires treatment with another antimicrobial agent
8. Pseudomonas aeruginosa as a baseline isolate
9. Severely impaired arterial blood supply and insufficiency (absence of arterial pulse) such that the likelihood of amputation of the infected anatomical site is within one month
10. Presence of hepatic disease, acute hepatic failure or acute decompensation of chronic hepatic failure
11. Abnormal laboratory values at admission to study:
11.1. Serum Glutamic-Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT) >45 IU
11.2. Alkaline phosphate or serum bilirubin >2 mg/dl
11.3. Hemoglobin <9 g/dl, WBC<1000 /mm3
11.4. Platelet count < 75000 /mm3
12. Impaired renal function (serum creatinine >1.5 ml/min) or those requiring peritoneal dialysis or hemodialysis
13. Use of other antimicrobial drugs after wound specimen for culture has been obtained. Prior anti-infective use, (<3 days of oral antibiotics and <1 day any injectable antibiotics) even up to the day of patient enrollment, would be acceptable if a culture is obtained showing the persistence of pathogen.
14. Clinical laboratory determinations outside of an acceptable range should be excluded unless the finding can be attributed to current drug(s) therapy
15. Patients requiring further surgical intervention that might influence the evaluation of response to study medication
16. Any other underlying conditions compromising the ability to respond to a bacterial infection. e.g. AIDS, corticosteroid, chemotherapy, immunocompromised.
17. Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
18. Any patient not reasonably expected to complete the trial

Recruitment start date

15/05/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

India

Trial participating centre

Maulana Azad Medical College and Hospital
New Delhi
100012
India

Sponsor information

Organisation

Ranbaxy Laboratories Ltd (India)

Sponsor details

Plot 90
Sect 32
Haryana
Gurgaon
122001
India
+91 124 4185741
Ganesh.Shetty@ranbaxy.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Ranbaxy laboratories Ltd (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes