Community-acquired PneumoniaNCT05606627
Correlation Between Antibiotic Resistance and Incidence of Sepsis in Community Acquired Pneumonia
An observational study of Community-acquired Pneumonia and Antibiotic Resistance, run by Assiut University.
Trial summary
Correlation between antibiotic resistance and incidence of sepsis in community acquired pneumonia in RICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Antibiotic Resistance, Sepsis
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to RICU with sever community acquired pneumonia.
Who may be able to join
- 1. Patients above 18 yrs. old. 2. Patients with sever community acquired bacterial pneumonia confirmed by clinical symptoms (CURB-65 scores >= 4) and culture.
- 3.Informed consent to participate in the study is provided.
Who cannot join
- 1. Patients below 18 yrs. old. 2. Patient don't meet the criteria of community acquired bacterial pneumonia (viral, fungal, chemical,…etc.).
- 3. Patients with comorbid respiratory diseases. 4. Patients with Hospital acquired pneumonia. 5. Patients receiving empirical antibiotics. 6. Patients receiving anti-TB drugs, systemic steroids or chemotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study on Correlation Between Antibiotics Resistance and Incidence of Sepsis in Community Acquired Pneumonia in RICU Patients, Assiut University Hospital.
Correlation between antibiotic resistance and incidence of sepsis in community acquired pneumonia in RICU patients.
Read the detailed description
Adult community-acquired pneumonia (CAP) is a leading cause of morbidity, often needing hospitalization, and an important cause of mortality, especially in severe cases with sepsis or requiring assisted ventilation[1]. Typical bacterial pathogens that cause CAP include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis[2].
Clinical diagnosis is based on a group of signs and symptoms related to lower respiratory tract infection with presence of fever >38ºC (>100ºF), cough, muco purulent sputum, pleuritic chest pain, dyspnoea, and new focal chest signs on examination such as crackles or bronchial breathing[3]. There are numerous tools such as the Pneumonia Severity Index (PSI) and the CURB-65 (confusion, urea, respiratory rate, blood pressure and age ≥65) score to identify and evaluate indication of ICU admission [4].Sever CAP patients may develop signs and symptoms of systemic inflammatory response syndrome (SIRS).
Systemic inflammatory response syndrome (SIRS) is an exaggerated defense response of the body to a noxious stressor (infection, trauma, surgery, acute inflammation, ischemia or reperfusion, or malignancy, to name a few) to localize and then eliminate the endogenous or exogenous source of the insult[8]. Criteria of SIRS heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state and one of the following risk factors should be considered at risk of sepsis:Looks unwell, Age greater than 65 years, Recent surgery, Immunocompromised (AIDS, chemotherapy, neutropenia, transplant, chronic steroids), Chronic illness (diabetes, renal failure, hepatic failure, cancer, alcoholism, IV drug use )[8]Table [1] .When SIRS caused by infectious cause (Bacteria, Vairus, Fungi,…etc) and associated with multiorgan dysfunction is defined as sepsis.
Sepsis and septic shock are medical emergencies, and studies recommend that treatment and resuscitation begin immediately[8]. Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is a life-threatening condition that happens when blood pressure drops to a dangerously low level after an infection[9]. Septic shock is defined by persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
Recent studies suggests that there is a relationship between antibiotic resistance and the incidence of sepsis in community-acquired bacterial pneumonia and considered it one of the most significant health complications that can result from antimicrobial resistance.As more germs become resistant to antimicrobial medicines used to treat infection, more people are at risk for developing sepsis.
According to WHO, widespread use and abuse of antibiotics have led to the rapid emergence and spread of antimicrobial resistance globally, and empirical management of CAP is rendered difficult (for a choice of drug, as most drugs are ineffective) by this phenomenon[5]. Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medic medicines making infections harder to treat and increasing the risk of disease spread, severe illness and death[6]. Four major AMR risk factor domains were identified: (1) sociodemographic factors (includes migrant status, low income and urban residence), (2) patient clinical information (includes disease status and certain laboratory results), (3) admission to healthcare settings (includes length of hospitalisation and performance of invasive procedures) and (4) drug exposure (includes current or prior antibiotic therapy)[7].
So , The primary end point of this study is assessment the correlation between drug resistance and incidence of sepsis and the secondry end point is improving mortality and morbidity of patients with sever CAP in ICU.
- Conditions
- Community-acquired Pneumonia, Antibiotic Resistance, Sepsis
- Medical subject headings
- Community-Acquired Pneumonia, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Define antibiotic resistant organisms 2.Assess correlation between antibiotic resistance and incidence of sepsis in CAP patiants 3. Assess incidence of sepsis in CAP patiants using SOFA score.
Measured: October 2022/ April 2024
Secondary outcomes (1)
1.Decrease MDR phenomenon 2.improving mortality and morbidity of patients with sever CAP in ICU.
Measured: October 2022/April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdelrhman Kotb Said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606627
- Sponsor's protocol ID
- Community Acquired pneumonia
- Status last verified
- Nov 2022
- First submitted
- 22 Oct 2022
- Last updated
- 7 Nov 2022
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Correlation Between Antibiotics Resistance and Incidence of Sepsis in Community Acquired Pneumonia in RICU Patients, Assiut University Hospital.
- ClinicalTrials.gov ID
- NCT05606627
- Acronym / sponsor ID
- Community Acquired pneumonia
- Conditions
- Community-acquired Pneumonia, Antibiotic Resistance, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 Nov 2022 (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.
Correlation between antibiotic resistance and incidence of sepsis in community acquired pneumonia in RICU patients.
Detailed description
Adult community-acquired pneumonia (CAP) is a leading cause of morbidity, often needing hospitalization, and an important cause of mortality, especially in severe cases with sepsis or requiring assisted ventilation[1]. Typical bacterial pathogens that cause CAP include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis[2].
Clinical diagnosis is based on a group of signs and symptoms related to lower respiratory tract infection with presence of fever >38ºC (>100ºF), cough, muco purulent sputum, pleuritic chest pain, dyspnoea, and new focal chest signs on examination such as crackles or bronchial breathing[3]. There are numerous tools such as the Pneumonia Severity Index (PSI) and the CURB-65 (confusion, urea, respiratory rate, blood pressure and age ≥65) score to identify and evaluate indication of ICU admission [4].Sever CAP patients may develop signs and symptoms of systemic inflammatory response syndrome (SIRS).
Systemic inflammatory response syndrome (SIRS) is an exaggerated defense response of the body to a noxious stressor (infection, trauma, surgery, acute inflammation, ischemia or reperfusion, or malignancy, to name a few) to localize and then eliminate the endogenous or exogenous source of the insult[8]. Criteria of SIRS heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state and one of the following risk factors should be considered at risk of sepsis:Looks unwell, Age greater than 65 years, Recent surgery, Immunocompromised (AIDS, chemotherapy, neutropenia, transplant, chronic steroids), Chronic illness (diabetes, renal failure, hepatic failure, cancer, alcoholism, IV drug use )[8]Table [1] .When SIRS caused by infectious cause (Bacteria, Vairus, Fungi,…etc) and associated with multiorgan dysfunction is defined as sepsis.
Sepsis and septic shock are medical emergencies, and studies recommend that treatment and resuscitation begin immediately[8]. Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is a life-threatening condition that happens when blood pressure drops to a dangerously low level after an infection[9]. Septic shock is defined by persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
Recent studies suggests that there is a relationship between antibiotic resistance and the incidence of sepsis in community-acquired bacterial pneumonia and considered it one of the most significant health complications that can result from antimicrobial resistance.As more germs become resistant to antimicrobial medicines used to treat infection, more people are at risk for developing sepsis.
According to WHO, widespread use and abuse of antibiotics have led to the rapid emergence and spread of antimicrobial resistance globally, and empirical management of CAP is rendered difficult (for a choice of drug, as most drugs are ineffective) by this phenomenon[5]. Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medic medicines making infections harder to treat and increasing the risk of disease spread, severe illness and death[6]. Four major AMR risk factor domains were identified: (1) sociodemographic factors (includes migrant status, low income and urban residence), (2) patient clinical information (includes disease status and certain laboratory results), (3) admission to healthcare settings (includes length of hospitalisation and performance of invasive procedures) and (4) drug exposure (includes current or prior antibiotic therapy)[7].
So , The primary end point of this study is assessment the correlation between drug resistance and incidence of sepsis and the secondry end point is improving mortality and morbidity of patients with sever CAP in ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to RICU with sever community acquired pneumonia.
Key inclusion criteria (2 listed)
- 1. Patients above 18 yrs. old. 2. Patients with sever community acquired bacterial pneumonia confirmed by clinical symptoms (CURB-65 scores >= 4) and culture.
- 3.Informed consent to participate in the study is provided.
Key exclusion criteria (2 listed)
- 1. Patients below 18 yrs. old. 2. Patient don't meet the criteria of community acquired bacterial pneumonia (viral, fungal, chemical,…etc.).
- 3. Patients with comorbid respiratory diseases. 4. Patients with Hospital acquired pneumonia. 5. Patients receiving empirical antibiotics. 6. Patients receiving anti-TB drugs, systemic steroids or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.Define antibiotic resistant organisms 2.Assess correlation between antibiotic resistance and incidence of sepsis in CAP patiants 3. Assess incidence of sepsis in CAP patiants using SOFA score.
Time frame: October 2022/ April 2024
1 secondary outcome
1.Decrease MDR phenomenon 2.improving mortality and morbidity of patients with sever CAP in ICU.
Time frame: October 2022/April 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia and Antibiotic Resistance, 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 2 inclusion and 2 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 7 Nov 2022. 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 Aya Abdelrhman Kotb (01069555261, ayaabdelrhman409@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Define antibiotic resistant organisms 2.Assess correlation between antibiotic resistance and incidence of sepsis in CAP patiants 3. Assess incidence of sepsis in CAP patiants using SOFA score. (time frame: October 2022/ April 2024). 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 7 Nov 2022.