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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05100407
Other study ID # MDR and predictive factors
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date May 15, 2022

Study information

Verified date March 2022
Source Kufa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date May 15, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Iraq Faculty of pharmacy /kufa university Najaf

Sponsors (1)

Lead Sponsor Collaborator
Kufa University

Country where clinical trial is conducted

Iraq, 

References & Publications (7)

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

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. pii: e18082. doi: 10.7554/eLife.18082. — View Citation

Mallah N, Rodríguez-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. — View 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. — View 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. Review. — View Citation

Rodríguez-Villodres Á, Martín-Gandul C, Peñalva G, Guisado-Gil AB, Crespo-Rivas JC, Pachón-Ibáñez 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). pii: 680. doi: 10.3390/antibiotics10060680. Review. — View Citation

Who.int. 2021. Antimicrobial resistance. [online] Available at: https://www.who.int/health-topics/antimicrobial-resistance

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of multidrug resistance bacteria in isolated patient specimen proportion of MDR bacteria that detected in isolated specimen based line value (zero months)
Primary Association of patient's factors with prevalence of multidrug resistance Bacteria. exploring the association between patient's factors and the prevalence of MDR bacteria by multivariate analysis based line value (zero months)
Secondary Prevalence of Methicillin resistance staph. Aureus (MERSA) proportion of participants with MERSA bacteria that detected in isolated specimen based line value (zero months)
Secondary Prevalence of vancomycin (-resistant Enterococci VRE) proportion of participants with VRE bacteria that detected in isolated specimen based line value (zero months)
Secondary Prevalence of extended spectrum ß lactamase producers (ESBL) proportion of participants with ESBL bacteria that detected in isolated specimen based line value (zero months)
Secondary Knowledge, attitude and practice (KAP) toward antibiotic use the score indicator of KAP through a module of KAP survey by 20 categorized questions the knowledge is individual understanding about antibiotic resistance the attitude is the perceptions and beliefs that respondents (+),(-) perceive towards antibiotic resistance the practice is the observable actions of individual towards antibiotic use based line value (zero months)
Secondary Risk factors for antibiotic resistance asses patient's predictive factors and their role in prevalence of multidrug resistance bacteria based line value (zero months)
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