Undifferentiated Febrile IllnessPhase 3NUFITNCT02773407
Nepal Undifferentiated Febrile Illness Trial
A Phase 3 study testing Azithromycin and Co-trimoxazole in people with Undifferentiated Febrile Illness, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Nepal.
Trial summary
The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Undifferentiated Febrile Illness
- What is being tested?
- Azithromycin and Co-trimoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesNepal
- Study dates
- 23 May 2016to 4 Aug 2019
- Phase
- Phase 3
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fever of ≥ 38.0°C and for ≥4 days without a focus of infection
- ≥ 2 years and <65 years of age
- Able to take tablets orally
- Patient residing in Kathmandu Valley
- Able to come for follow up
- Can be reached by telephone/mobile phone 24 hours a day.
- Written informed consent to participate in the study including assent for minors in addition to parental consent.
Who cannot join
- Fever >14 days
- Pregnancy
- Obtundation
- Shock
- Visible jaundice
- Presence of signs of gastrointestinal bleeding
Show all 10Show fewer
- History of hypersensitivity to either of the trial drugs
- Patient requiring intravenous antibiotic or hospital admission for any reason.
- Contraindication of drug for any reason (e.g. drug interactions).
- Any patient fulfilling inclusion criteria but already on antimicrobials and responding clinically to the treatment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Parallel Group, Double Blinded, 1:1, Randomized Controlled Phase III Trial of Co-trimoxazole Versus Azithromycin for the Treatment of Undifferentiated Fever In Nepal
The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal
Read the detailed description
Fever is one of the most common presenting symptoms of patients presenting to health centers in Nepal. Many of the times, it is difficult to diagnose the cause of the fever by initial history, clinical examination and basic laboratory tests and the patents are treated as presumed enteric fever or fever without focus needing antimicrobials. In fact there are various causes of similarly presenting febrile illnesses including typhoid, paratyphoid, murine typhus, scrub typhus etc.
Many of the traditionally used drugs including fluoroquinolones are now resistant against enteric fever in south asia. Oral azithromycin is now commonly used to treat undifferentiated febrile illness and remains effective against enteric fever. Many physicians now also use co-trimoxazole as it was very commonly used in the treatment of enteric fever in the past. Resistance to co-trimoxazole emerged two decades ago, but has subsequently largely disappeared and nearly all Salmonella Typhi and Paratyphi A strains from Nepal are now susceptible. Anecdotal reports claim that it seems to work very well against undifferentiated febrile illness in Nepal; it is largely stocked in government health facilities and is a popular and cheap treatment option.
Both azithromycin and co-trimoxazole are available in Nepal and are extensively used in the treatment of undifferentiated febrile illness. Therefore it is important to know the better oral option to treat enteric fever and other febrile illnesses and also to have an alternative oral treatment in case resistance to azithromycin emerges.
The investigators purpose to conduct a head to head, parallel group, 1:1, double blinded randomized controlled trial to compare azithromycin and co-trimoxazole for the treatment of undifferentiated febrile illness and determine the best empirical treatment for undifferentiated febrile illness in Nepal.
- Conditions
- Undifferentiated Febrile Illness
- Being tested
- Azithromycin, Co-trimoxazole
- Keywords
- Undifferentiated febrile illness, Azithromycin, Cotrimoxazole, Efficacy, Enteric fever, Fever clearance time
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Co-trimoxazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Azithromycin tablets 20mg/kg/day for 7 days (Maximum dose 1000mg/day) Receives: Drug: Azithromycin |
| Group B | Active comparator | Co-trimoxazole tablets (Trimethoprim 10 mg/kg+Sulphamethoxazole 50 mg/kg) in two divided doses everyday for 7 days (maximum 3000mg/day) Receives: Drug: Co-trimoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever clearance time
time from the first dose of a study drug until a temperature ≤37.5°C for at least 2 days
Measured: at least 2 days
Secondary outcomes (7)
Fever failure
defined by fever clearance time (FCT) >7 days post treatment initiation;
Measured: over 7 days post treatment initiation
Need rescue treatment
Requirement for rescue treatment as judged by the Research Medical Officer (RMO) and Attending Physician (AP)
Measured: within 63 days
Microbiological failure
Blood culture positivity for S. Typhi or an S. Paratyphi
Measured: on day 7 of treatment
Relapse
Culture-confirmed or syndromic enteric fever relapse
Measured: within 28 days of initiation of treatment
The development of any complication
any complication: e.g. clinically significant bleeding, fall in the Glasgow Coma Score, perforation of the gastrointestinal tract and hospital admission
Measured: within 28 days of initiation of treatment
Time-to-treatment failure
the time from the first dose of treatment until the date of the earliest failure event
Measured: within 63 days
Adverse events
grade 3/4 adverse events, serious adverse events, adverse events of any grade leading to modification of study drug dose or interruption/early discontinuation
Measured: within 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start23 May 2016
- Primary completion4 Aug 2019
- Study completion4 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Undifferentiated Febrile IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Buddha Basnyat, MBBS,MSc,MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773407
- Sponsor's protocol ID
- 18NP
- Acronym
- NUFIT
- Status last verified
- Dec 2023
- First submitted
- 5 May 2016
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymised individual participant data will be made available to researcher and public as a supporting material via open access journal and/or upon request by qualified research groups
Publications
Crump JA, Kirk MD. Estimating the Burden of Febrile Illnesses. PLoS Negl Trop Dis. 2015 Dec 3;9(12):e0004040. doi: 10.1371/journal.pntd.0004040. eCollection 2015 Dec. No abstract available.
PubMed 26633014Zimmerman MD, Murdoch DR, Rozmajzl PJ, Basnyat B, Woods CW, Richards AL, Belbase RH, Hammer DA, Anderson TP, Reller LB. Murine typhus and febrile illness, Nepal. Emerg Infect Dis. 2008 Oct;14(10):1656-9. doi: 10.3201/eid1410.080236.
PubMed 18826840Thompson CN, Blacksell SD, Paris DH, Arjyal A, Karkey A, Dongol S, Giri A, Dolecek C, Day N, Baker S, Thwaites G, Farrar J, Basnyat B. Undifferentiated febrile illness in Kathmandu, Nepal. Am J Trop Med Hyg. 2015 Apr;92(4):875-878. doi: 10.4269/ajtmh.14-0709. Epub 2015 Feb 9.
PubMed 25667056Koirala S, Basnyat B, Arjyal A, Shilpakar O, Shrestha K, Shrestha R, Shrestha UM, Agrawal K, Koirala KD, Thapa SD, Karkey A, Dongol S, Giri A, Shakya M, Pathak KR, Campbell J, Baker S, Farrar J, Wolbers M, Dolecek C. Gatifloxacin versus ofloxacin for the treatment of uncomplicated enteric fever in Nepal: an open-label, randomized, controlled trial. PLoS Negl Trop Dis. 2013 Oct 31;7(10):e2523. doi: 10.1371/journal.pntd.0002523. eCollection 2013.
PubMed 24282626Arjyal A , Basnyat B, Nhan HT, Koirala S, Giri A, Joshi N, et al. A randomised controlled trial of gatifloxacin versus ceftriaxone for the treatment of uncomplicated enteric fever in Nepal. Submitted. 2015;3099(15):1-11
Dolecek C, Tran TP, Nguyen NR, Le TP, Ha V, Phung QT, Doan CD, Nguyen TB, Duong TL, Luong BH, Nguyen TB, Nguyen TA, Pham ND, Mai NL, Phan VB, Vo AH, Nguyen VM, Tran TT, Tran TC, Schultsz C, Dunstan SJ, Stepniewska K, Campbell JI, To SD, Basnyat B, Nguyen VV, Nguyen VS, Nguyen TC, Tran TH, Farrar J. A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam. PLoS One. 2008 May 21;3(5):e2188. doi: 10.1371/journal.pone.0002188.
PubMed 18493312Parry CM, Ho VA, Phuong le T, Bay PV, Lanh MN, Tung le T, Tham NT, Wain J, Hien TT, Farrar JJ. Randomized controlled comparison of ofloxacin, azithromycin, and an ofloxacin-azithromycin combination for treatment of multidrug-resistant and nalidixic acid-resistant typhoid fever. Antimicrob Agents Chemother. 2007 Mar;51(3):819-25. doi: 10.1128/AAC.00447-06. Epub 2006 Dec 4.
PubMed 17145784Chinh NT, Parry CM, Ly NT, Ha HD, Thong MX, Diep TS, Wain J, White NJ, Farrar JJ. A randomized controlled comparison of azithromycin and ofloxacin for treatment of multidrug-resistant or nalidixic acid-resistant enteric fever. Antimicrob Agents Chemother. 2000 Jul;44(7):1855-9. doi: 10.1128/AAC.44.7.1855-1859.2000.
PubMed 10858343Chand HJ, Rijal KR, Neupane B, Sharma VK, Jha B. Re-emergence of susceptibility to conventional first line drugs in Salmonella isolates from enteric fever patients in Nepal. J Infect Dev Ctries. 2014 Nov 13;8(11):1483-7. doi: 10.3855/jidc.4228.
PubMed 25390062Pandit A, Arjyal A, Day JN, Paudyal B, Dangol S, Zimmerman MD, Yadav B, Stepniewska K, Campbell JI, Dolecek C, Farrar JJ, Basnyat B. An open randomized comparison of gatifloxacin versus cefixime for the treatment of uncomplicated enteric fever. PLoS One. 2007 Jun 27;2(6):e542. doi: 10.1371/journal.pone.0000542.
PubMed 17593957Arjyal A, Basnyat B, Koirala S, Karkey A, Dongol S, Agrawaal KK, Shakya N, Shrestha K, Sharma M, Lama S, Shrestha K, Khatri NS, Shrestha U, Campbell JI, Baker S, Farrar J, Wolbers M, Dolecek C. Gatifloxacin versus chloramphenicol for uncomplicated enteric fever: an open-label, randomised, controlled trial. Lancet Infect Dis. 2011 Jun;11(6):445-54. doi: 10.1016/S1473-3099(11)70089-5. Epub 2011 Apr 29.
PubMed 21531174Giri A, Karkey A, Dangol S, Arjyal A, Pokharel S, Rijal S, Gajurel D, Sharma R, Lamsal K, Shrestha P, Prajapati G, Pathak S, Shrestha SR, K C RK, Pandey S, Thapa A, Shrestha N, Thapa RK, Poudyal B, Phuong DNT, Baker S, Kestelyn E, Geskus R, Thwaites G, Basnyat B. Trimethoprim-sulfamethoxazole Versus Azithromycin for the Treatment of Undifferentiated Febrile Illness in Nepal: A Double-blind, Randomized, Placebo-controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1478-e1486. doi: 10.1093/cid/ciaa1489.
PubMed 32991678Pokharel S, Basnyat B, Arjyal A, Mahat SP, Kc RK, Bhuju A, Poudyal B, Kestelyn E, Shrestha R, Phuong DNT, Thapa R, Karki M, Dongol S, Karkey A, Wolbers M, Baker S, Thwaites G. Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial. Trials. 2017 Oct 2;18(1):450. doi: 10.1186/s13063-017-2199-6.
PubMed 28969659
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group, Double Blinded, 1:1, Randomized Controlled Phase III Trial of Co-trimoxazole Versus Azithromycin for the Treatment of Undifferentiated Fever In Nepal
- ClinicalTrials.gov ID
- NCT02773407
- Acronym / sponsor ID
- NUFIT / 18NP
- Conditions
- Undifferentiated Febrile Illness
- Keywords
- Undifferentiated febrile illness, Azithromycin, Cotrimoxazole, Efficacy, Enteric fever, Fever clearance time
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust
- Study start
- 23 May 2016 (actual)
- Primary completion
- 4 Aug 2019 (actual)
- Study completion
- 4 Aug 2019 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal
Detailed description
Fever is one of the most common presenting symptoms of patients presenting to health centers in Nepal. Many of the times, it is difficult to diagnose the cause of the fever by initial history, clinical examination and basic laboratory tests and the patents are treated as presumed enteric fever or fever without focus needing antimicrobials. In fact there are various causes of similarly presenting febrile illnesses including typhoid, paratyphoid, murine typhus, scrub typhus etc.
Many of the traditionally used drugs including fluoroquinolones are now resistant against enteric fever in south asia. Oral azithromycin is now commonly used to treat undifferentiated febrile illness and remains effective against enteric fever. Many physicians now also use co-trimoxazole as it was very commonly used in the treatment of enteric fever in the past. Resistance to co-trimoxazole emerged two decades ago, but has subsequently largely disappeared and nearly all Salmonella Typhi and Paratyphi A strains from Nepal are now susceptible. Anecdotal reports claim that it seems to work very well against undifferentiated febrile illness in Nepal; it is largely stocked in government health facilities and is a popular and cheap treatment option.
Both azithromycin and co-trimoxazole are available in Nepal and are extensively used in the treatment of undifferentiated febrile illness. Therefore it is important to know the better oral option to treat enteric fever and other febrile illnesses and also to have an alternative oral treatment in case resistance to azithromycin emerges.
The investigators purpose to conduct a head to head, parallel group, 1:1, double blinded randomized controlled trial to compare azithromycin and co-trimoxazole for the treatment of undifferentiated febrile illness and determine the best empirical treatment for undifferentiated febrile illness in Nepal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: AzithromycinAzithromycin tablets 20mg/kg/day for 7 days (Maximum dose 1000mg/day) |
| Group B | Active comparator | Drug: Co-trimoxazoleCo-trimoxazole tablets (Trimethoprim 10 mg/kg+Sulphamethoxazole 50 mg/kg) in two divided doses everyday for 7 days (maximum 3000mg/day) |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Fever of ≥ 38.0°C and for ≥4 days without a focus of infection
- ≥ 2 years and <65 years of age
- Able to take tablets orally
- Patient residing in Kathmandu Valley
- Able to come for follow up
Key exclusion criteria (10 listed)
- Fever >14 days
- Pregnancy
- Obtundation
- Shock
- Visible jaundice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | Group A |
| Co-trimoxazole | Drug | Group B |
Primary outcome
Fever clearance time
Time frame: at least 2 days
time from the first dose of a study drug until a temperature ≤37.5°C for at least 2 days
7 secondary outcomes
Fever failure
Time frame: over 7 days post treatment initiation
Need rescue treatment
Time frame: within 63 days
Microbiological failure
Time frame: on day 7 of treatment
Relapse
Time frame: within 28 days of initiation of treatment
The development of any complication
Time frame: within 28 days of initiation of treatment
Time-to-treatment failure
Time frame: within 63 days
Adverse events
Time frame: within 63 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 26633014Crump JA, Kirk MD. Estimating the Burden of Febrile Illnesses. PLoS Negl Trop Dis. 2015 Dec 3;9(12):e0004040. doi: 10.1371/journal.pntd.0004040. eCollection 2015 Dec. No abstract available.
- Background: PubMed 18826840Zimmerman MD, Murdoch DR, Rozmajzl PJ, Basnyat B, Woods CW, Richards AL, Belbase RH, Hammer DA, Anderson TP, Reller LB. Murine typhus and febrile illness, Nepal. Emerg Infect Dis. 2008 Oct;14(10):1656-9. doi: 10.3201/eid1410.080236.
- Background: PubMed 25667056Thompson CN, Blacksell SD, Paris DH, Arjyal A, Karkey A, Dongol S, Giri A, Dolecek C, Day N, Baker S, Thwaites G, Farrar J, Basnyat B. Undifferentiated febrile illness in Kathmandu, Nepal. Am J Trop Med Hyg. 2015 Apr;92(4):875-878. doi: 10.4269/ajtmh.14-0709. Epub 2015 Feb 9.
- Background: PubMed 24282626Koirala S, Basnyat B, Arjyal A, Shilpakar O, Shrestha K, Shrestha R, Shrestha UM, Agrawal K, Koirala KD, Thapa SD, Karkey A, Dongol S, Giri A, Shakya M, Pathak KR, Campbell J, Baker S, Farrar J, Wolbers M, Dolecek C. Gatifloxacin versus ofloxacin for the treatment of uncomplicated enteric fever in Nepal: an open-label, randomized, controlled trial. PLoS Negl Trop Dis. 2013 Oct 31;7(10):e2523. doi: 10.1371/journal.pntd.0002523. eCollection 2013.
- BackgroundArjyal A , Basnyat B, Nhan HT, Koirala S, Giri A, Joshi N, et al. A randomised controlled trial of gatifloxacin versus ceftriaxone for the treatment of uncomplicated enteric fever in Nepal. Submitted. 2015;3099(15):1-11
- Background: PubMed 18493312Dolecek C, Tran TP, Nguyen NR, Le TP, Ha V, Phung QT, Doan CD, Nguyen TB, Duong TL, Luong BH, Nguyen TB, Nguyen TA, Pham ND, Mai NL, Phan VB, Vo AH, Nguyen VM, Tran TT, Tran TC, Schultsz C, Dunstan SJ, Stepniewska K, Campbell JI, To SD, Basnyat B, Nguyen VV, Nguyen VS, Nguyen TC, Tran TH, Farrar J. A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam. PLoS One. 2008 May 21;3(5):e2188. doi: 10.1371/journal.pone.0002188.
- Background: PubMed 17145784Parry CM, Ho VA, Phuong le T, Bay PV, Lanh MN, Tung le T, Tham NT, Wain J, Hien TT, Farrar JJ. Randomized controlled comparison of ofloxacin, azithromycin, and an ofloxacin-azithromycin combination for treatment of multidrug-resistant and nalidixic acid-resistant typhoid fever. Antimicrob Agents Chemother. 2007 Mar;51(3):819-25. doi: 10.1128/AAC.00447-06. Epub 2006 Dec 4.
- Background: PubMed 10858343Chinh NT, Parry CM, Ly NT, Ha HD, Thong MX, Diep TS, Wain J, White NJ, Farrar JJ. A randomized controlled comparison of azithromycin and ofloxacin for treatment of multidrug-resistant or nalidixic acid-resistant enteric fever. Antimicrob Agents Chemother. 2000 Jul;44(7):1855-9. doi: 10.1128/AAC.44.7.1855-1859.2000.
- Background: PubMed 25390062Chand HJ, Rijal KR, Neupane B, Sharma VK, Jha B. Re-emergence of susceptibility to conventional first line drugs in Salmonella isolates from enteric fever patients in Nepal. J Infect Dev Ctries. 2014 Nov 13;8(11):1483-7. doi: 10.3855/jidc.4228.
- Background: PubMed 17593957Pandit A, Arjyal A, Day JN, Paudyal B, Dangol S, Zimmerman MD, Yadav B, Stepniewska K, Campbell JI, Dolecek C, Farrar JJ, Basnyat B. An open randomized comparison of gatifloxacin versus cefixime for the treatment of uncomplicated enteric fever. PLoS One. 2007 Jun 27;2(6):e542. doi: 10.1371/journal.pone.0000542.
- Background: PubMed 21531174Arjyal A, Basnyat B, Koirala S, Karkey A, Dongol S, Agrawaal KK, Shakya N, Shrestha K, Sharma M, Lama S, Shrestha K, Khatri NS, Shrestha U, Campbell JI, Baker S, Farrar J, Wolbers M, Dolecek C. Gatifloxacin versus chloramphenicol for uncomplicated enteric fever: an open-label, randomised, controlled trial. Lancet Infect Dis. 2011 Jun;11(6):445-54. doi: 10.1016/S1473-3099(11)70089-5. Epub 2011 Apr 29.
- Derived from this study: PubMed 32991678Giri A, Karkey A, Dangol S, Arjyal A, Pokharel S, Rijal S, Gajurel D, Sharma R, Lamsal K, Shrestha P, Prajapati G, Pathak S, Shrestha SR, K C RK, Pandey S, Thapa A, Shrestha N, Thapa RK, Poudyal B, Phuong DNT, Baker S, Kestelyn E, Geskus R, Thwaites G, Basnyat B. Trimethoprim-sulfamethoxazole Versus Azithromycin for the Treatment of Undifferentiated Febrile Illness in Nepal: A Double-blind, Randomized, Placebo-controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1478-e1486. doi: 10.1093/cid/ciaa1489.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data will be made available to researcher and public as a supporting material via open access journal and/or upon request by qualified research groups
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buddha Basnyat, MBBS,MSc,MD principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin and Co-trimoxazole in people with Undifferentiated Febrile Illness, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Nepal.
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 7 inclusion and 10 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fever clearance time (time frame: at least 2 days). 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 NCT02773407, which also lists 13 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 6 Dec 2023.