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Multi-antibiotic ResistanceNCT05100407

Factors Impacting the Prevalence of MDR Bacteria

An observational study of Multi-antibiotic Resistance, run by Kufa University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Multi-antibiotic Resistance
How many people
400 participants
Where
1 siteIraq
Study dates
1 Mar 2022to 15 May 2022
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: patients hospitalized with bacterial infection and screened for MDR bacteria in AL-Zahraa teaching hospital or AL-Sader medical city

Who may be able to join

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

Who cannot join

  • patients with no growth media
  • patients who cannot communicated

Trial locations and contacts

1 site in 1 country.

Iraq1 site

  • Faculty of pharmacy /kufa university

    Najaf

Other trials in Iraq

About this study

Official title: Evaluation of the Prevalence and Antibiotic Susceptibility Pattern of Multidrug Resistance Bacteria and Its Association With Patients' Predictive Factors

  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
Read the 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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of multidrug resistance bacteria in isolated patient specimen

    proportion of MDR bacteria that detected in isolated specimen

    Measured: based line value (zero months)

  2. 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

    Measured: based line value (zero months)

Secondary outcomes (5)

  1. Prevalence of Methicillin resistance staph. Aureus (MERSA)

    proportion of participants with MERSA bacteria that detected in isolated specimen

    Measured: based line value (zero months)

  2. Prevalence of vancomycin (-resistant Enterococci VRE)

    proportion of participants with VRE bacteria that detected in isolated specimen

    Measured: based line value (zero months)

  3. Prevalence of extended spectrum β lactamase producers (ESBL)

    proportion of participants with ESBL bacteria that detected in isolated specimen

    Measured: based line value (zero months)

  4. 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

    Measured: based line value (zero months)

  5. Risk factors for antibiotic resistance

    asses patient's predictive factors and their role in prevalence of multidrug resistance bacteria

    Measured: based line value (zero months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start1 Mar 2022
  3. Primary completion1 May 2022
  4. Study completion15 May 2022

Resources

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
Cross-sectional
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100407
Sponsor's protocol ID
MDR and predictive factors
Status last verified
Mar 2022
First submitted
18 Oct 2021
Last updated
18 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26343252

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

  • 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

  • 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.

    PubMed 33244041

  • 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.

    PubMed 33603416

  • 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.

    PubMed 34200238

  • 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.

    PubMed 27599374

Questions about this trial

What is this clinical trial studying?

An observational study of Multi-antibiotic Resistance, run by Kufa University at 1 site in Iraq.

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: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of multidrug resistance bacteria in isolated patient specimen (time frame: based line value (zero months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05100407, which also lists 7 linked publications.

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 18 Aug 2022.

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