Anaerobic Bacterial InfectionNCT03266341
Detection of Anaerobes in Different Clinicalsamples
An observational study of Anaerobic Bacterial Infection, run by Assiut University.
Trial summary
Early detection of anaerobic bacteria to avoid its serious comlications Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anaerobic Bacterial Infection
- What is being tested?
- Cultures
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Take different samples for dtection of the causitive anaerobe
Who may be able to join
- Patient with infection organism not yet detected
Who cannot join
- patients with infection organism is already detected
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Anaerobes in Different Clinical Samples
Early detection of anaerobic bacteria to avoid its serious comlications
Read the detailed description
Infections caused by anaerobic bacteria are common and may be serious and life-threatening.Obligately anaerobic bacteria do not grow on solid media in room air (0.04% carbon dioxide and 21% oxygen); facultatively anaerobic bacteria can grow in the presence or absence of air. Microaerophilic bacteria do not grow at all aerobically or grow poorly, but grow better under 10% carbon dioxide or anaerobically. Anaerobic bacteria can be divided into strict anaerobes that can not grow in the presence of more than 0.5% oxygen and moderate anaerobic bacteria that are able of growing between 2 and 8% oxygen. Anaerobic bacteria usually do not possess catalase, but some can generate superoxide dismutase which protects them from oxygen.
Anaerobes are the predominant components of the bacterial flora of normal human skin and mucous membranes, and are therefore a common cause of bacterial infections of endogenous origin. Infections due to anaerobic bacteria can evolve all body systems and sites . The predominant ones include: abdominal, pelvic, respiratory, and skin and soft tissues infections. Because of their fastidious nature, they are difficult to isolate from infectious sites and are often overlooked. Failure to direct therapy against these organisms often leads to clinical failures. Their isolation requires appropriate methods of collection, transportation, and cultivation of specimens. Treatment of anaerobic bacterial infection is complicated by the slow growth of these organisms, which makes diagnosis in the laboratory possible only after several days, by their often polymicrobial nature and by the growing resistance of anaerobic bacteria to antimicrobial agent.
Almost all anaerobic infections originate from the patient's own microflora. Poor blood supply and tissue necrosis lower the oxidation-reduction potential and favor the growth of anaerobes. Any condition that lowers the blood supply to an affected area can predispose to anaerobic infection. Therefore, foreign body, malignancy, surgery, edema, shock, traum and vascular disease may predispose to anaerobic infection. Previous infection with aerobic or facultative organisms also may make the local tissue conditions more favorable for the growth of anaerobic organisms. The human defense mechanisms also may be impaired by anaerobic conditions .
- Conditions
- Anaerobic Bacterial Infection
- Being tested
- Cultures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CulturesDiagnostic test
Take different samples anddetection of anaerobes on enriched blood agar and other selective anaerobic cultures
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of anaerobes in different clinical samples
Samples will be in oculated on different anaerobic media
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start15 Sep 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaerobic Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Samir, Assiut University
- Investigators
- Sohair Mohamed ahmed, Proffisor, Study director, ProffisorAsmaa Omar ahmef, Assistant prof, Principal investigator, Assistant pro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266341
- Sponsor's protocol ID
- Anaerobes detection in samples
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Anaerobes in Different Clinical Samples
- ClinicalTrials.gov ID
- NCT03266341
- Acronym / sponsor ID
- Anaerobes detection in samples
- Conditions
- Anaerobic Bacterial Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early detection of anaerobic bacteria to avoid its serious comlications
Detailed description
Infections caused by anaerobic bacteria are common and may be serious and life-threatening.Obligately anaerobic bacteria do not grow on solid media in room air (0.04% carbon dioxide and 21% oxygen); facultatively anaerobic bacteria can grow in the presence or absence of air. Microaerophilic bacteria do not grow at all aerobically or grow poorly, but grow better under 10% carbon dioxide or anaerobically. Anaerobic bacteria can be divided into strict anaerobes that can not grow in the presence of more than 0.5% oxygen and moderate anaerobic bacteria that are able of growing between 2 and 8% oxygen. Anaerobic bacteria usually do not possess catalase, but some can generate superoxide dismutase which protects them from oxygen.
Anaerobes are the predominant components of the bacterial flora of normal human skin and mucous membranes, and are therefore a common cause of bacterial infections of endogenous origin. Infections due to anaerobic bacteria can evolve all body systems and sites . The predominant ones include: abdominal, pelvic, respiratory, and skin and soft tissues infections. Because of their fastidious nature, they are difficult to isolate from infectious sites and are often overlooked. Failure to direct therapy against these organisms often leads to clinical failures. Their isolation requires appropriate methods of collection, transportation, and cultivation of specimens. Treatment of anaerobic bacterial infection is complicated by the slow growth of these organisms, which makes diagnosis in the laboratory possible only after several days, by their often polymicrobial nature and by the growing resistance of anaerobic bacteria to antimicrobial agent.
Almost all anaerobic infections originate from the patient's own microflora. Poor blood supply and tissue necrosis lower the oxidation-reduction potential and favor the growth of anaerobes. Any condition that lowers the blood supply to an affected area can predispose to anaerobic infection. Therefore, foreign body, malignancy, surgery, edema, shock, traum and vascular disease may predispose to anaerobic infection. Previous infection with aerobic or facultative organisms also may make the local tissue conditions more favorable for the growth of anaerobic organisms. The human defense mechanisms also may be impaired by anaerobic conditions .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Take different samples for dtection of the causitive anaerobe
Key inclusion criteria (1 listed)
- Patient with infection organism not yet detected
Key exclusion criteria (1 listed)
- patients with infection organism is already detected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CulturesTake different samples anddetection of anaerobes on enriched blood agar and other selective anaerobic cultures | Diagnostic test | – |
Primary outcome
Detection of anaerobes in different clinical samples
Time frame: 2years
Samples will be in oculated on different anaerobic media
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohair Mohamed ahmed, Proffisor study director
Proffisor
Asmaa Omar ahmef, Assistant prof principal investigator
Assistant pro
Questions about this trial
What is this clinical trial studying?
An observational study of Anaerobic Bacterial Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa Ali samir hussien mohamed, Master (01018612254, Safaa.samir191@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of anaerobes in different clinical samples (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.