Multicentre, randomised controlled clinical trial to compare minocycline plus rifampicin with linezolid against MRSA in complex skin and skin structure infections (cSSSI).

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 225

Inclusion Criteria

Patients will be enrolled in this study only if they meet all of the following numbered criteria:
1.Hospitalised with clinical evidence of at least 1 of the following MRSA infections:
•Ulcers
•First or second degree burns of less than 20% of body surface area with concomitant signs of cellulitis (excluding third degree burns and burns >20% of body surface area)
•Major abscess (see exclusion criteria for qualifications)
•Deep or extensive cellulitis, and/or
•Wounds – trauma or post surgical

2.Presence of purulent or seropurulent drainage or at least 3 of the following signs and symptoms:
•Drainage and/or discharge
•Erythema (extending at least 1 cm beyond a wound edge)
•Swelling and/or induration
•Heat and/or localized warmth
•Pain and/or tenderness to palpation

3.At least 1 of the following conditions considered to be pathogen-related:
•Fever (temperature >38?C/100.4?F orally, rectally, or tympanically),
•Elevated total peripheral white blood cells (WBCs) >10,000/mm3, or
•>15% immature neutrophils (bands), regardless of total peripheral WBC count

4.Accessible infection site for culture or a bacteraemia where a culture cannot be obtained from the site of infection

5.Adult at least 18 years of age

6.Written informed consent to participate in the study before any study-specific procedures are performed

7.If of childbearing potential, must be using, or be prepared to use, a mechanical method of contraception (e.g. condom) during the study.
8.If female, has a negative serum pregnancy test (serum beta-human Chorionic Gonadotropin (hCG)) result immediately prior to enrolment. If obtaining the serum pregnancy result would cause a delay in treatment, the patient can be entered on the basis of a negative urine pregnancy test result. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG, pending results of the serum test. The patient must end study medication therapy if the subsequent serum pregnancy test is positive

Patients who have received an antibiotic for a cSSSI but have not responded and are considered a failure on that treatment regimen are eligible for this study provided they have a positive MRSA baseline culture.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following will exclude a patient from enrolment into the study.
1.Women who are pregnant or breast-feeding

2.Pre menopausal women who refuse to substitute oral contraception during treatment by contraception using mechanical means (e.g. condom)

3.Known or suspected hypersensitivity to linezolid, minocycline or rifampicin

4.Clinical or laboratory evidence of significant impairment of hepatic function, i.e. bilirubin of >3x upper limit of normal range, AST or ALT >5x upper limit of normal range, proven histological liver changes on biopsy

5.Major abscess associated with diabetic foot conditions

6.Suspected or confirmed osteomyelitis

7.Treatment with other antimicrobials with activity against MRSA within 24hr prior to study inclusion. However, treatment failures from other therapy may be entered provided there is a positive baseline culture for MRSA.

8.In the case of a mixed infection where it is considered necessary to concomitantly treat with a Gram-negative agent, this agent must have no activity against MRSA.

9.Patients with a high probability of death within a week of study entry

10.Haemodialysis patients or those requiring other means of renal support for end stage renal disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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