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| ID | Type | Description | Link |
|---|---|---|---|
| B1811030 |
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This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. Data will be collected only from subjects providing informed consent.
Healthcare visit.
Extension Rationale:
In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.
Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Intensive Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study so no intervention in the patient. | Other | Observational study so no intervention in the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT) | Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection. | End of Treatment (on the day of last dose of study treatment) or up to 25 months |
| Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit | Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection. | Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose | Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. |
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Inclusion Criteria:
Exclusion Criteria:
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Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23772047 | Derived | Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140. | |
| 23772045 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This was a prospective observational study, non-comparative, conducted in 26 French Intensive Care Units (ICUs). Patients who were hospitalized in ICUs and presented with complicated infections of skin or soft tissues or complicated intra-abdominal infections and who met the inclusion criteria of the study were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tigecycline | Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tigecycline | Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT) | Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection. | Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment (on the day of last dose of study treatment) or up to 25 months |
|
Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tigecycline | Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiorgan failure | General disorders | MedDRA version 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting / Nausea | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Baseline (Inclusion) through last dose of study treatment or up to 25 months |
| Mean Duration (Days) of Treatment With Tigecycline | Baseline (Inclusion) through last dose of study treatment or up to 25 months |
| Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT | Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. | Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months |
| Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit | Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. | Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months |
| Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture | Microbiological sampling results categorized as a positive blood culture (presence of infection). | Post-baseline (Day 1) through last dose of study treatment or up to 25 months |
| Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination | Microbiological sampling results categorized according to direct examination (identification of the class of germs). | Post-baseline (Day 1) through last dose of study treatment or up to 25 months |
| Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143. |
| 23772042 | Derived | Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141. |
| Resistant germ |
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| New infection |
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| Resistance germ and technical failure |
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| Persistance of fever undetermined origin |
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| Antibiotic changed, no apparent reason |
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| Infectious origin not probable |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Percentage of participants per type of infection: Intra-abdominal | Nosocomial=hospital acquired infection. Participants may be represented in > 1 category. Infection N=88, Peritonitis N=68, Localization N=88. | Number | percentage of participants |
|
| Percentage of participants per type of infection: Infection of skin and soft tissue | Nosocomial=hospital acquired infection. Participants may be represented in > 1 category. Infection N=29, Dermo-panniculis N=29, Localization N=17. | Number | percentage of participants |
|
| Percentage of participants per type of infection: Other infections | Nosocomial=hospital acquired infection. Participants may be represented in > 1 category. Infection N=56, Localization N=56. | Number | percentage of participants |
|
| Mean Simplified Acute Physiology Score II (SAPSII): Integer score | Severity of disease measurement 24 hours after ICU admission based on 17 variables. Result values transformed to an integer point score from 0 (less severe disease state) to 163 (more severe disease state) and can also be used to calculate a corresponding mortality between 0% (no predicted mortality) and 100% (greatest predicted mortality). N=147 | Mean | Standard Deviation | scores on a scale |
|
| Mean Sepsis-related Organ Failure Assessment (SOFA) score | Assess extent of organ function or rate of failure during ICU admission. Based on scores for 6 systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological) graded from 0 (normal) to 4 (most abnormal) with a potential total score of 0 to 24; higher score indicates greater system abnormality. | Mean | Standard Deviation | scores on a scale |
|
| Percentage of participants per reason for choice of treatment with Tigecycline | Participants may be represented in > 1 category. Multi-resistant bacteria (MRB). | Number | percentage of participants |
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| Percentage of participants per co-morbid (concomitant) diseases | Participants may be represented in > 1 category. Immunosuppression (Immuno). | Number | percentage of participants |
|
| Percentage of participants with antibiotic treatment(s) taken 30 days prior to Tigecycline treatment | Number | percentage of participants |
|
| Percentage of participants with microbiological sampling results: positive blood culture | Microbiological sampling results categorized as a positive blood culture (presence of infection); N=145 | Number | percentage of participants |
|
| Percentage of participants with microbiological sampling results: direct examination | Microbiological sampling results categorized according to direct examination (identification of the class of germs). Participants may be represented in >1 category. N=87 | Number | percentage of participants |
|
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. |
|
|
| Primary | Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit | Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection. | ITT population; N=number of participants with analyzable data at observation. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months |
|
|
|
| Secondary | Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose | Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. | ITT population | Posted | Number | percentage of participants | Baseline (Inclusion) through last dose of study treatment or up to 25 months |
|
|
|
| Secondary | Mean Duration (Days) of Treatment With Tigecycline | ITT population | Posted | Mean | Standard Deviation | days | Baseline (Inclusion) through last dose of study treatment or up to 25 months |
|
|
|
| Secondary | Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT | Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. | ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation. | Posted | Number | percentage of participants | Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months |
|
|
|
| Secondary | Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit | Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. | ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation. | Posted | Number | percentage of participants | Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months |
|
|
|
| Secondary | Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture | Microbiological sampling results categorized as a positive blood culture (presence of infection). | ITT population. N=number of participants with analyzable data at observation. | Posted | Number | percentage of participants | Post-baseline (Day 1) through last dose of study treatment or up to 25 months |
|
|
|
| Secondary | Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination | Microbiological sampling results categorized according to direct examination (identification of the class of germs). | ITT population. N=number of participants with analyzable data at observation; participants may be represented in >1 category. | Posted | Number | percentage of participants | Post-baseline (Day 1) through last dose of study treatment or up to 25 months |
|
|
|
| 26 |
| 156 |
| 9 |
| 156 |
| Drug resistance | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Amount of liquid intra-abdominal localized | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Colitis ischaemia | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Intestinal infarction | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Pancreatic necrosis | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Small intestine obstruction | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Purulent discharge | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA version 12.0 | Systematic Assessment |
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| Atrio ventricular dissociation | Cardiac disorders | MedDRA version 12.0 | Systematic Assessment |
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| Carotid artery dissection | Nervous system disorders | MedDRA version 12.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA version 12.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Lack of efficacy of the drug (ineffectiveness of the drug) | General disorders | MedDRA version 12.0 | Systematic Assessment |
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| Hemorrhagic shock (Shock due to an haemorrhage) | Vascular disorders | MedDRA version 12.0 | Systematic Assessment |
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| Arterial injury (lesion of an artery) | Injury, poisoning and procedural complications | MedDRA version 12.0 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA version 12.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA version 12.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Maintenance dose: 50 mg twice a day + Other |
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| Title | Measurements |
|---|---|
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| Penicillins: Piperacillin / Tazobactam |
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| Title | Measurements |
|---|---|
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| Penicillins: Piperacillin / Tazobactam |
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| Title | Measurements |
|---|---|
|
| Gram positive bacilli |
|