Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05292508 |
| Other study ID # |
1-2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 26, 2023 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Patan Academy of Health Sciences |
| Contact |
Amit Arjyal, MBBS, DPhil |
| Phone |
+9779864478329 |
| Email |
amitarjyal[@]pahs.edu.np |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In Health Posts of rural areas operated by the Government of Nepal, there are limitations of
tests to differentiate between bacterial and viral infections. Due to this, health workers
are obliged to prescribe antimicrobials (antibacterials) just on the basis of clinical
features. This can lead to irrational use of antimicrobials, consequently contributing to
antimicrobial resistance. C-reactive protein is the marker of inflammation which rises during
bacterial infection but rarely rises during viral infection. The investigators wish to
compare the effect on antimicrobial usage of using CRP(C-Reactive Protein) test, a rapid
diagnostic test used to differentiate bacterial and viral infection, with usual standard of
care, by carrying out a cluster-randomized controlled trial. The investigators plan to carry
out this study in eight Health Posts of Resunga, Dhurkot and Gulmi-Durbar Municipalities of
Gulmi District. The investigators will randomly allocate four Health Posts (clusters) to the
intervention arm- CRP TESTS in addition to Usual Standard of Care, and four Health Posts
(clusters) to the control arm- Usual Standard of Care Alone. The investigators plan to study
all patients above one year of age presenting with fever or a history of reported fever with
a duration of up to 7 days in Health Posts. Primarily, the investigators will assess the
rates of antimicrobial use per patient who presents with febrile illness. Secondarily, the
investigators will also assess the outcome of illness of the patient such as need for
subsequent hospital admission or severe or complicated illness. This testing method will
supplement the existing methods to differentiate bacterial and viral infections based on
history and clinical examination by health professionals as a part of usual standard of care
in the Health Posts included in this study.
Description:
The World Health Organization (WHO) defines antimicrobial resistance (AMR) as a situation
where drugs used to treat microbial infection caused by bacteria, viruses, fungi and
parasites no longer work to treat infection because of the changes in these microbes over
time. Though this process of development of AMR is a natural process, it is accelerated by
the overuse and misuse of antimicrobials (Mladenovic-Antic et al, 2016, pp.532-537). There
were an estimated 1.27 million deaths attributable to bacterial AMR globally in 2019 (Murray
et al, 2022). It is estimated that in India every year around sixty thousand newborns die due
to AMR (Laxminarayan et al, 2013, pp.1057-1098). As big as the death toll due to AMR is, the
economic costs are also significant. Even in a setting of a developed country like the US,
direct healthcare cost of AMR is over 6 billion US dollars (CDC, 2019). Nepal is one of the
developing countries of the world located in South Asia between India and China. AMR is an
increasing problem in Nepal and some of the most common causes for it are excessive use of
antimicrobials in animal husbandry and unnecessary use of antimicrobials for treatment of
febrile illness (Rijal et al, 2021, pp. 1-14; Acharya and Wilson, 2021, p.105). Currently,
bacteria like Escherichia coli, Klebsiella pneumoniae, Streptococcus pneumoniae, Shigella
spp., Vibrio cholera, Neisseria gonorrheae and Staphylococcus aureus are increasingly
resistant to the most first-line and some second-line antimicrobials (Acharya and Wilson,
2021 p.105; Basnyat et al, 2015, pp.102-111). Thus antimicrobial resistance (AMR) presents a
great threat to public health.
Nepal has its own National Antibiotic Treatment Guideline and according to this even the
smallest government healthcare units like health posts can prescribe antimicrobials. These
health posts lack microbiology laboratory access and the health worker has to prescribe
antimicrobials based upon their history and examination findings which may lead to
unnecessary prescription of antimicrobials against viral illness. This challenge of
unavailability of laboratory tests can be tackled by introducing point-of-care rapid
diagnostic test to detect C-reactive protein to differentiate between bacterial and viral
infections. C-reactive protein is the marker of inflammation which rises in blood during
bacterial infection but rarely rises during viral infection (Phommasone et al, 2015, pp.1-6).
This method has already been used in other developing countries like Laos, Thailand, Myanmar,
Malaysia and Vietnam, which have similar socio-economic conditions like that of Nepal
(Phommasone et al, 2015, pp.1-6; Althaus et al, 2019, pp.e119-e131; Lubell et al, 2018,
pp.1-6; Haenssgen et al, 2018, pp.1-12). Antimicrobials are rarely prescribed based on an
absolute certainty of a bacterial infection. The use of point-of-care rapid diagnostic test
offers an easy, affordable and a working solution to this problem and helps in judicial use
of antimicrobials (O'Neill, 2016). Although it is known that CRP testing can differentiate
bacterial and viral infections, the extent to which it can reduce antimicrobial use in a
rural health-post setting of Nepal and thus play a role in limiting the emergence of
antimicrobial resistance is not known. If this study shows significant reduction in
antimicrobial prescription without any adverse clinical outcome, the test kit can be
implemented nationally in all low resource health care settings in Nepal.
