Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05606627 |
| Other study ID # |
Community Acquired pneumonia |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2022 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
November 2022 |
| Source |
Assiut University |
| Contact |
Aya Abdelrhman Kotb |
| Phone |
01069555261 |
| Email |
ayaabdelrhman409[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Correlation between antibiotic resistance and incidence of sepsis in community acquired
pneumonia in RICU patients.
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.
