Clinical trial NCT05100407: Factors Impacting the Prevalence of MDR Bacteria
Official title: Evaluation of the Prevalence and Antibiotic Susceptibility Pattern of Multidrug Resistance Bacteria and Its Association With Patients' Predictive Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi-antibiotic Resistance
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized with bacterial infection and screened for MDR bacteria in AL-Zahraa teaching hospital or AL-Sader medical city

Brief summary: 1. To determine the prevalence of multidrug resistance bacteria in patient with different infections
2. To evaluate patients' predictive risk factors of antimicrobial resistance
3. To assess the association between patients' factors and prevalence of MDR bacteria

Detailed description: Antimicrobial resistance is one of the most critical public health issue in this century . WHO declared antimicrobial resistance as one of the top ten global health threats that impend the effective management and prevention of evolving infections .

Antimicrobial resistance nowadays poses a big challenge because of the emerging of resistance to the antibiotics that previously effective and development of multidrug resistance infections with subsequent increase in morbidity, mortality and financial loss .

In spite of WHO health strategies that taken to face multidrug resistance problem, the burden of antimicrobial resistance in Europe is compared with combined burden of influenza and HIVS .while in USA the estimated antibiotics resistance infections is 2.8 millions and the related deaths exceeded 35,000 every year and expected to reach to ten million deaths with collective cost of 100 trillion USD annually in 2050 .

Numerous studies reported that self-medications, improper prescription, overuse of antibiotics, deficiency of antibiotics susceptibility test and limited knowledge and attitude of population towards antibiotics are the main factors that lead to antibiotics efficacy being reduced with long hospital stay. Other studies stated that the predictive indicators of MDR tragedy are age, gender, comorbidities, previous hospital stay or antibiotic use .

In low and middle income countries like IRAQ there is a difficulty in estimation the scope of antibiotics resistance problem and its evolving over time due to the lack of surveillance, besides alarmingly excessive antibiotics consumption added other challenges and urged us to aim this study .

Eligibility criteria: Inclusion Criteria:

* patients who were screened for MDR bacteria
* patients who accepted to participate in the study

Exclusion Criteria:

* patients with no growth media
* patients who cannot communicated

Primary outcomes:
measure: Prevalence of multidrug resistance bacteria in isolated patient specimen
timeFrame: based line value (zero months)
measure: Association of patient's factors with prevalence of multidrug resistance Bacteria.
timeFrame: based line value (zero months)
Secondary outcomes:
measure: Prevalence of Methicillin resistance staph. Aureus (MERSA)
timeFrame: based line value (zero months)
measure: Prevalence of vancomycin (-resistant Enterococci VRE)
timeFrame: based line value (zero months)
measure: Prevalence of extended spectrum β lactamase producers (ESBL)
timeFrame: based line value (zero months)
measure: Knowledge, attitude and practice (KAP) toward antibiotic use
timeFrame: based line value (zero months)
measure: Risk factors for antibiotic resistance
timeFrame: based line value (zero months)
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: Faculty of pharmacy /kufa university
Study officials:
affiliation: college of pharmacy kufa university
name: Hayder Asaad, assist. prof
role: STUDY_DIRECTOR
References:
citation: Prestinaci F, Pezzotti P, Pantosti A. Antimicrobial resistance: a global multifaceted phenomenon. Pathog Glob Health. 2015;109(7):309-18. doi: 10.1179/2047773215Y.0000000030. Epub 2015 Sep 7.
citation: Who.int. 2021. Antimicrobial resistance. [online] Available at: https://www.who.int/health-topics/antimicrobial-resistance
citation: Bhardwaj, K., Shenoy M, S., Baliga, S., Unnikrishnan, B. and Baliga, B., 2021. Knowledge, attitude, and practices related to antibiotic use and resistance among the general public of coastal south Karnataka, India - A cross-sectional survey. Clinical Epidemiology and Global Health, 11, p.100717
citation: Mallah N, Rodriguez-Cano R, Figueiras A, Takkouche B. Design, reliability and construct validity of a Knowledge, Attitude and Practice questionnaire on personal use of antibiotics in Spain. Sci Rep. 2020 Nov 26;10(1):20668. doi: 10.1038/s41598-020-77769-6.
citation: Marzan M, Islam DZ, Lugova H, Krishnapillai A, Haque M, Islam S. Knowledge, Attitudes, and Practices of Antimicrobial Uses and Resistance Among Public University Students in Bangladesh. Infect Drug Resist. 2021 Feb 11;14:519-533. doi: 10.2147/IDR.S289964. eCollection 2021.
citation: Rodriguez-Villodres A, Martin-Gandul C, Penalva G, Guisado-Gil AB, Crespo-Rivas JC, Pachon-Ibanez ME, Lepe JA, Cisneros JM. Prevalence and Risk Factors for Multidrug-Resistant Organisms Colonization in Long-Term Care Facilities Around the World: A Review. Antibiotics (Basel). 2021 Jun 7;10(6):680. doi: 10.3390/antibiotics10060680.
citation: Lim C, Takahashi E, Hongsuwan M, Wuthiekanun V, Thamlikitkul V, Hinjoy S, Day NP, Peacock SJ, Limmathurotsakul D. Epidemiology and burden of multidrug-resistant bacterial infection in a developing country. Elife. 2016 Sep 6;5:e18082. doi: 10.7554/eLife.18082.