EUCTR2006-000514-21-NLActive, not recruitingPhase 1
Multicenter, randomized, open-label, clinical study on the agreement ofScintimun® Granulocyte and labeled 99mTc-White Blood Cells in diagnosinginfection/inflammation by immunoscintigraphy in peripheral bone and jointswith suspected osteomyelitis.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CIS bio International
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The patients screened positively for the study must fulfill all the following criteria:
- •1. Male or female (if female of child-bearing potential, negative pregnancy test required before any radiotracer administration),
- •2. Age ³ 18 years,
- •3. Patients with suspected or documented osteomyelitis (acute, subacute, chronic) in the peripheral skeleton including patients with loosening of joint prosthesis and patients with diabetic foot. In addition, at least one of the following signs or symptoms is required: localized pain, nonhealing skin ulceration, fever > 37.8°C for at least 3 days, leukocyte count in excess of the upper normal limits, erythrocyte sedimentation rate in excess of the upper normal limits, radiographic findings suggestive of osteomyelitis, or positive blood or wound cultures,
- •4. Patients who have signed a written informed consent form to participate in the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patients displaying any of the following criteria will not be included:
- •1. Pregnant women and women with a positive pregnancy test prior to the first study drug administration,
- •2. Breastfeeding women and women of child bearing potential not using a reliable means of contraception,
- •3. Patients with a known allergy to mouse proteins or a positive mouse proteins-specific Ig E test (allergy test) prior to the first study drug administration,
- •4. Patients with a positive HAMA test prior to the first study drug administration
- •5. Patients with rare hereditary problems of fructose intolerance,
- •6. Severe disease or surgery (except for orthopedic reasons) within the last 4 weeks prior to the first study drug administration,
- •7. A history of hypersensitivity to one or several medications (abnormal or idiosyncratic reactions to a drug),
- •8. Patients with leukocyte count < 6.109/L (6,000/mm3),
- •9. The use of non-steroid anti-inflammatory drugs and corticosteroids within 3 days prior to the first injection and up to 24 hours after the last injection,
- •10. Receipt of cancer chemotherapy and immunosuppressive drugs or immunomodulators within 4 weeks prior to study entry,
- •11. Patient showing laboratory parameters which in the opinion of the investigator preclude participation for reasons of the patient’s safety.
- •12. Nuclear medicine diagnostic procedure within 2 days prior to the first injection,
- •13. Participation in another clinical study within one month prior to screening,
- •14. Uncooperative, in the investigator's opinion,
- •15. Linguistic or psychological inability to sign the informed consent form and/or take part in the study.
Investigators
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