E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with suspected or documented osteomyelitis in the peripheral skeleton including patients with loosening of joint prosthesis or diabetic foot. 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 upper normal limits, erythrocyte sedimentation rate in excess of upper normal limits, radiographic findings suggestive of osteomyelitis, or positive blood or wound cultures. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the present study is to assess the agreement rate of Scintimun® Granulocyte and 99mTc-WBCs with regard to the diagnosis of infection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and independent readers in the absence of a standard of reference (SOR) to evaluate the true status. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the image quality, and evaluate the safety of the two products, in particular, the possible HAMA (Human Anti-Mouse Antibodies) factor induction after the investigational product administration. Additional objective will be determination of agreement rates between Scintimun® Granulocyte and 99mTc-WBCs per reader and based on the evaluation of clinical investigators. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary analysis is the evaluation of the agreement rate of Scintimun® Granulocyte and labeled WBCs with regard to the diagnosis of infection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and independent readers in a blinded read. The primary efficacy variable will be calculated as an average across the reader results ("average reader") as primary analysis and separately for each reader as secondary analysis. The endpoint "agreement rate" was chosen in absence of an adequate standard of reference, so that diagnostic parameters like sensitivity and specificity could not be calculated. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |