Typhoid FeverPhase 4ACT-South AsiaNCT04349826
The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)
A Phase 4 study testing Azithromycin and Cefixime in people with Typhoid Fever, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Nepal.
Trial summary
Typhoid and paratyphoid (enteric) fever affects more than 11 million children and adults globally each year including 7 million in South Asia. Up to 1% of patients who get typhoid may die of the disease and, in those that survive, a prolonged period of ill health and catastrophic financial cost to the family may… Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Azithromycin and Cefixime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,150 participants
- Where
- 1 siteNepal
- Study dates
- 23 May 2021to 31 Dec 2025
- Phase
- Phase 4
- 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
- A history of fever at presentation for ≥ 72 hours and a documented fever (≥37.5oC (axillary) or ≥38oC (oral))
- Age ≥ 2 years (and ≥ 10kg) to 65 years
- No clear focus of infection on initial clinical evaluation
- Malaria rapid Diagnostic test( RDT) negative; dengue nonstructural protein(NS) 1 RDT negative; scrub typhus RDT negative; c-reactive protein(CRP) rapid test ≥10 mg/L
- Able to take oral treatment
- Able to attend for follow-up and can be contacted by telephone
- Written fully informed consent to participate in the study including assent for children in addition to parental/legal guardian consent.
Who cannot join
- History of fever for >14 days
- Pregnant or positive pregnancy test or breast-feeding
- Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
- Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalisation
- Being treated for TB or HIV or severe acute malnutrition
- Patients with cardiac disease
Show all 11Show fewer
- Patient requiring intravenous antibiotics for any reason
- Previous history of hypersensitivity to any of the treatment options
- Either of the trial drugs are contraindicated for any reason (e.g. drug interactions)
- Has received azithromycin or cefixime in the last five days
- Receiving another antimicrobial and responding clinically to the treatment as judged by the attending clinician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycin and Cefixime Combination Versus Azithromycin Alone for the Out-patient Treatment of Clinically Suspected or Confirmed Uncomplicated Typhoid Fever in South Asia; a Randomised Controlled Trial
Typhoid and paratyphoid (enteric) fever affects more than 11 million children and adults globally each year including 7 million in South Asia. Up to 1% of patients who get typhoid may die of the disease and, in those that survive, a prolonged period of ill health and catastrophic financial cost to the family may follow. In the last 20 years, treatment of typhoid fever with a 7-day course of a single oral antimicrobial, such as ciprofloxacin, cefixime or azithromycin, given in an out-patient setting has led to patient recovery in 4 to 6 days without the need for expensive hospitalization. Increasing antimicrobial resistance in Asia and sub-Saharan Africa, threatens the effectiveness of these treatments and increases the risk of prolonged illness and severe disease. The recent emergence of a particularly resistant typhoid strain in Pakistan, and subsequent international spread, adds urgency to this problem and Salmonella is now listed as a high (Priority 2) pathogen by world health organisation.
Treatment with combinations of antimicrobials may be more effective for treating typhoid fever and mitigate the problems of resistance. This suggestion is based on expert opinion but not backed up by good quality evidence. The ACT-South Asia study aims to compare a combination of azithromycin and cefixime with azithromycin alone in the outpatient treatment of clinically suspected and confirmed uncomplicated typhoid fever. The total recruitment will be 1500 patients across sites in Bangladesh, India, Nepal and Pakistan. A placebo (sugar pill) will be used instead of cefixime in the single drug arm so that neither the patient nor the study team know which patient is receiving which treatment.Investigators will assess whether treatment outcomes are better with the combination after one week of treatment and at one and three month follow-up. Both antimicrobials are widely used and have excellent safety profiles. If the combination treatment is better than the single antibiotic treatment, this will be an important result for patients across South Asia and other typhoid endemic areas. This study will additionally investigate the financial implications for families and health system.
- Conditions
- Typhoid Fever
- Being tested
- Azithromycin, Cefixime, Placebo
- Keywords
- Uncomplicated Typhoid Fever, Azithromycin, Cefixime, treatment failure
- 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
Azithromycin 20 mg/kg/day for 7 days
CefiximeDrug
cefixime 20-30 mg/kg/day for 7 days
PlaceboDrug
cefixime-matched placebo for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin+Cefixime | Active comparator | Azithromycin 20mg/kg/day oral dose once daily (maximum 1gm/day) AND Cefixime 20-30mg/kg/day oral dose in two divided doses (maximum 400mg bd) for 7 days. Receives: Drug: Azithromycin; Drug: Cefixime |
| Azithromycin+placebo | Placebo comparator | Azithromycin 20mg/kg/day oral dose once daily (Max 1gm/day) for 7 days AND Cefixime-matched placebo for 7 days. Receives: Drug: Azithromycin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
A composite outcome of treatment failure by the 28th day after the initiation of treatment will be defined by either of the following events: 1.Clinical failure: persistence of fever on day 7 (168 h) post treatment initiation OR The need for rescue treatment as judged by the Trial Clinician OR The development of any complication (e.g., clinically significant bleeding, fall in the Glasgow Coma Scale score, perforation of the gastrointestinal tract) OR Syndromic enteric fever relapse within 28 days of initiation of treatment. 2.Microbiological failure: a positive blood-culture for S. Typhi or S. Paratyphi on day 7 of treatment regardless of the presence of fever (microbiological failure) OR blood culture-confirmed typhoid fever relapse within 28 days of initiation of treatment.
Measured: Within 28 days of treatment initiation
Secondary outcomes (6)
Fever clearance time (FCT) in patients in each treatment arm
The FCT will be the time from the first dose of a study drug until a temperature of < 37.5°C (axillary); < 38.0°C (oral) has been achieved
Measured: at least 2 days
Time from onset of treatment to treatment failure
The time to treatment failure will be the time from the first dose of a study drug until an event occurs defined as a treatment failure
Measured: Within 28 days of treatment initiation
Time from symptom onset to treatment failure
The time to treatment failure will be the time from the day of the first symptom until an event occurs defined as a treatment failure
Measured: Within 28 days of treatment initiation
Adverse event
Adverse events will be graded (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 90 days
faecal carriage of S.Typhi or S.Paratyphi
Positive culture of faeces sample for S.Typhi or S.Paratyphi
Measured: One and three month follow-up
cost effectiveness of treatment
The incremental cost-effectiveness ratio (ICER) will comprise of the total costs per case, real outpatient and in-patient costs, total direct and indirect costs for the family and healthcare system and health outcomes converted to Disability Adjusted Life Years (DALYs). The cost per DALY averted will be compared against multipliers of the gross domestic product/capita in each of the four countries to establish the cost-effectiveness of the combination regimen.
Measured: Initiation of treatment and one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start23 May 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Typhoid FeverStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Medical Research Council, Department for International Development, United Kingdom, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Buddha Basnyat, MBBS,Msc,MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349826
- Sponsor's protocol ID
- 25NP
- Acronym
- ACT-South Asia
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2020
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data will be made available to researcher and public as supporting material via open access journal and /or upon request by qualified research group.
Publications
Butler T, Sridhar CB, Daga MK, Pathak K, Pandit RB, Khakhria R, Potkar CN, Zelasky MT, Johnson RB. Treatment of typhoid fever with azithromycin versus chloramphenicol in a randomized multicentre trial in India. J Antimicrob Chemother. 1999 Aug;44(2):243-50. doi: 10.1093/jac/44.2.243.
PubMed 10473232Chinh 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 10858343Trivedi NA, Shah PC. A meta-analysis comparing the safety and efficacy of azithromycin over the alternate drugs used for treatment of uncomplicated enteric fever. J Postgrad Med. 2012 Apr-Jun;58(2):112-8. doi: 10.4103/0022-3859.97172.
PubMed 22718054Dolecek 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 17145784Girgis NI, Butler T, Frenck RW, Sultan Y, Brown FM, Tribble D, Khakhria R. Azithromycin versus ciprofloxacin for treatment of uncomplicated typhoid fever in a randomized trial in Egypt that included patients with multidrug resistance. Antimicrob Agents Chemother. 1999 Jun;43(6):1441-4. doi: 10.1128/AAC.43.6.1441.
PubMed 10348767Basnyat B, Adhikari S, Shrestha P, Budhathoki S, Hossain MS, Ahmed N, Dongol S, Maharjan N, Shilpakar O, Gajurel D, Shrestha D, Sharma SK, Shakoor S, Basaula YN, Ojha S, Karki L, Kestelyn E, Wolbers M, Thwaites GE, Ahmed T, Qamar FN, Karkey A, Parry CM; ACT-South Asia Collaborative Group. Azithromycin with or without cefixime for suspected or culture-confirmed uncomplicated typhoid fever in Nepal, Bangladesh, and Pakistan (ACT-South Asia): a double-blind, parallel-group, randomised, placebo-controlled, phase 4 trial. Lancet Infect Dis. 2026 Aug 20:S1473-3099(26)00358-0. doi: 10.1016/S1473-3099(26)00358-0. Online ahead of print.
PubMed 42624818Giri A, Karkey A, Dongol S, Arjyal A, Maharjan A, Veeraraghavan B, Paudyal B, Dolecek C, Gajurel D, Phuong DNT, Thanh DP, Qamar F, Kang G, Hien HV, John J, Lawson K, Wolbers M, Hossain MS, Sharifuzzaman M, Luangasanatip N, Maharjan N, Olliaro P, Rupali P, Shakya R, Shakoor S, Rijal S, Qureshi S, Baker S, Joshi S, Ahmed T, Darton T, Bao TN, Lubell Y, Kestelyn E, Thwaites G, Parry CM, Basnyat B. Azithromycin and cefixime combination versus azithromycin alone for the out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia: a randomised controlled trial protocol. Wellcome Open Res. 2021 Nov 12;6:207. doi: 10.12688/wellcomeopenres.16801.2. eCollection 2021.
PubMed 35097222
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin and Cefixime Combination Versus Azithromycin Alone for the Out-patient Treatment of Clinically Suspected or Confirmed Uncomplicated Typhoid Fever in South Asia; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04349826
- Acronym / sponsor ID
- ACT-South Asia / 25NP
- Conditions
- Typhoid Fever
- Keywords
- Uncomplicated Typhoid Fever, Azithromycin, Cefixime, treatment failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,150 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- University of Oxford, Medical Research Council, Department for International Development, United Kingdom, Wellcome Trust
- Study start
- 23 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
Typhoid and paratyphoid (enteric) fever affects more than 11 million children and adults globally each year including 7 million in South Asia. Up to 1% of patients who get typhoid may die of the disease and, in those that survive, a prolonged period of ill health and catastrophic financial cost to the family may follow. In the last 20 years, treatment of typhoid fever with a 7-day course of a single oral antimicrobial, such as ciprofloxacin, cefixime or azithromycin, given in an out-patient setting has led to patient recovery in 4 to 6 days without the need for expensive hospitalization. Increasing antimicrobial resistance in Asia and sub-Saharan Africa, threatens the effectiveness of these treatments and increases the risk of prolonged illness and severe disease. The recent emergence of a particularly resistant typhoid strain in Pakistan, and subsequent international spread, adds urgency to this problem and Salmonella is now listed as a high (Priority 2) pathogen by world health organisation.
Treatment with combinations of antimicrobials may be more effective for treating typhoid fever and mitigate the problems of resistance. This suggestion is based on expert opinion but not backed up by good quality evidence. The ACT-South Asia study aims to compare a combination of azithromycin and cefixime with azithromycin alone in the outpatient treatment of clinically suspected and confirmed uncomplicated typhoid fever. The total recruitment will be 1500 patients across sites in Bangladesh, India, Nepal and Pakistan. A placebo (sugar pill) will be used instead of cefixime in the single drug arm so that neither the patient nor the study team know which patient is receiving which treatment.Investigators will assess whether treatment outcomes are better with the combination after one week of treatment and at one and three month follow-up. Both antimicrobials are widely used and have excellent safety profiles. If the combination treatment is better than the single antibiotic treatment, this will be an important result for patients across South Asia and other typhoid endemic areas. This study will additionally investigate the financial implications for families and health system.
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 |
|---|---|---|
| Azithromycin+Cefixime | Active comparator | Drug: Azithromycin, Drug: CefiximeAzithromycin 20mg/kg/day oral dose once daily (maximum 1gm/day) AND Cefixime 20-30mg/kg/day oral dose in two divided doses (maximum 400mg bd) for 7 days. |
| Azithromycin+placebo | Placebo comparator | Drug: Azithromycin, Drug: PlaceboAzithromycin 20mg/kg/day oral dose once daily (Max 1gm/day) for 7 days AND Cefixime-matched placebo for 7 days. |
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)
- A history of fever at presentation for ≥ 72 hours and a documented fever (≥37.5oC (axillary) or ≥38oC (oral))
- Age ≥ 2 years (and ≥ 10kg) to 65 years
- No clear focus of infection on initial clinical evaluation
- Malaria rapid Diagnostic test( RDT) negative; dengue nonstructural protein(NS) 1 RDT negative; scrub typhus RDT negative; c-reactive protein(CRP) rapid test ≥10 mg/L
- Able to take oral treatment
Key exclusion criteria (11 listed)
- History of fever for >14 days
- Pregnant or positive pregnancy test or breast-feeding
- Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
- Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalisation
- Being treated for TB or HIV or severe acute malnutrition
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 |
|---|---|---|
| AzithromycinAzithromycin 20 mg/kg/day for 7 days | Drug | Azithromycin+Cefixime, Azithromycin+placebo |
| Cefiximecefixime 20-30 mg/kg/day for 7 days | Drug | Azithromycin+Cefixime |
| Placebocefixime-matched placebo for 7 days | Drug | Azithromycin+placebo |
Primary outcome
Treatment Failure
Time frame: Within 28 days of treatment initiation
A composite outcome of treatment failure by the 28th day after the initiation of treatment will be defined by either of the following events: 1.Clinical failure: persistence of fever on day 7 (168 h) post treatment initiation OR The need for rescue treatment as judged by the Trial Clinician OR The development of any complication (e.g., clinically significant bleeding, fall in the Glasgow Coma Scale score, perforation of the gastrointestinal tract) OR Syndromic enteric fever relapse within 28 days of initiation of treatment. 2.Microbiological failure: a positive blood-culture for S. Typhi or S. Paratyphi on day 7 of treatment regardless of the presence of fever (microbiological failure) OR blood culture-confirmed typhoid fever relapse within 28 days of initiation of treatment.
6 secondary outcomes
Fever clearance time (FCT) in patients in each treatment arm
Time frame: at least 2 days
Time from onset of treatment to treatment failure
Time frame: Within 28 days of treatment initiation
Time from symptom onset to treatment failure
Time frame: Within 28 days of treatment initiation
Adverse event
Time frame: Within 90 days
faecal carriage of S.Typhi or S.Paratyphi
Time frame: One and three month follow-up
cost effectiveness of treatment
Time frame: Initiation of treatment and one month follow-up visit
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 15 Jan 2026.
- Background: PubMed 10473232Butler T, Sridhar CB, Daga MK, Pathak K, Pandit RB, Khakhria R, Potkar CN, Zelasky MT, Johnson RB. Treatment of typhoid fever with azithromycin versus chloramphenicol in a randomized multicentre trial in India. J Antimicrob Chemother. 1999 Aug;44(2):243-50. doi: 10.1093/jac/44.2.243.
- 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.
- Results publication: PubMed 22718054Trivedi NA, Shah PC. A meta-analysis comparing the safety and efficacy of azithromycin over the alternate drugs used for treatment of uncomplicated enteric fever. J Postgrad Med. 2012 Apr-Jun;58(2):112-8. doi: 10.4103/0022-3859.97172.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 10348767Girgis NI, Butler T, Frenck RW, Sultan Y, Brown FM, Tribble D, Khakhria R. Azithromycin versus ciprofloxacin for treatment of uncomplicated typhoid fever in a randomized trial in Egypt that included patients with multidrug resistance. Antimicrob Agents Chemother. 1999 Jun;43(6):1441-4. doi: 10.1128/AAC.43.6.1441.
- Derived from this study: PubMed 42624818Basnyat B, Adhikari S, Shrestha P, Budhathoki S, Hossain MS, Ahmed N, Dongol S, Maharjan N, Shilpakar O, Gajurel D, Shrestha D, Sharma SK, Shakoor S, Basaula YN, Ojha S, Karki L, Kestelyn E, Wolbers M, Thwaites GE, Ahmed T, Qamar FN, Karkey A, Parry CM; ACT-South Asia Collaborative Group. Azithromycin with or without cefixime for suspected or culture-confirmed uncomplicated typhoid fever in Nepal, Bangladesh, and Pakistan (ACT-South Asia): a double-blind, parallel-group, randomised, placebo-controlled, phase 4 trial. Lancet Infect Dis. 2026 Aug 20:S1473-3099(26)00358-0. doi: 10.1016/S1473-3099(26)00358-0. Online ahead of print.
- Derived from this study: PubMed 35097222Giri A, Karkey A, Dongol S, Arjyal A, Maharjan A, Veeraraghavan B, Paudyal B, Dolecek C, Gajurel D, Phuong DNT, Thanh DP, Qamar F, Kang G, Hien HV, John J, Lawson K, Wolbers M, Hossain MS, Sharifuzzaman M, Luangasanatip N, Maharjan N, Olliaro P, Rupali P, Shakya R, Shakoor S, Rijal S, Qureshi S, Baker S, Joshi S, Ahmed T, Darton T, Bao TN, Lubell Y, Kestelyn E, Thwaites G, Parry CM, Basnyat B. Azithromycin and cefixime combination versus azithromycin alone for the out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia: a randomised controlled trial protocol. Wellcome Open Res. 2021 Nov 12;6:207. doi: 10.12688/wellcomeopenres.16801.2. eCollection 2021.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data will be made available to researcher and public as supporting material via open access journal and /or upon request by qualified research group.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Cefixime in people with Typhoid Fever, run by Oxford University Clinical Research Unit, Vietnam at 1 site 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 11 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 15 Jan 2026. 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 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Treatment Failure (time frame: Within 28 days of treatment initiation). 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 NCT04349826, which also lists 8 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 15 Jan 2026.