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Treatment of Adults Patients with Acute Bacterial Rhinosinusitis: Official Practice Guideline of the Infectious Diseases and Tropical Medicine Research Center Advisory Committee

Author(s):
Soheil RoshanzamiriSoheil Roshanzamiri1, Amirali JahanshahiAmirali Jahanshahi2, Davood YadegariniaDavood Yadegarinia2, Masoud MardaniMasoud MardaniMasoud Mardani ORCID2, Shervin ShokohiShervin ShokohiShervin Shokohi ORCID2, Amir RajabiAmir Rajabi3, Nima DehghanNima Dehghan3, Pooya VahediPooya Vahedi3, Mohammad Hossein RamezaniMohammad Hossein Ramezani3, Ilad Alavi DarazamIlad Alavi DarazamIlad Alavi Darazam ORCID2, 4,*
1Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Archives of Clinical Infectious Diseases:Vol. 20, issue 5; e162500
Published online:Jul 29, 2025
Article type:Review Article
Received:May 05, 2025
Accepted:Jul 17, 2025
How to Cite:Roshanzamiri S, Jahanshahi A, Yadegarinia D, Mardani M, Shokohi S, et al. Treatment of Adults Patients with Acute Bacterial Rhinosinusitis: Official Practice Guideline of the Infectious Diseases and Tropical Medicine Research Center Advisory Committee.Arch Clin Infect Dis.2025;20(5):e162500.https://doi.org/10.5812/archcid-162500.

Abstract

Context:

Acute bacterial rhinosinusitis (ABRS) is a significant public health concern, affecting approximately 15% of the population annually, with a higher prevalence among women. The bacterial etiology primarily includes Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Due to regional variations in bacterial resistance patterns, there is a critical need for localized and evidence-based guidelines for better management in Iranian patients.

Evidence Acquisition:

A multidisciplinary team reviewed literature from Iranian and international databases published between January 1990 and 2024. Studies included epidemiological data on ABRS prevalence, bacterial resistance patterns, and clinical outcomes.

Results:

First-line empirical antibiotic therapy for uncomplicated ABRS in Iran includes amoxicillin-clavulanate (500 mg/125 mg three times daily or 875 mg/125 mg twice daily). In cases with high antibiotic resistance, high-dose amoxicillin-clavulanate (2000 mg/125 mg extended-release tablets twice daily) is preferred. Respiratory fluoroquinolones (levofloxacin or moxifloxacin) are recommended for penicillin-allergic patients, with alternative options for non-type I hypersensitivity cases.

Conclusions:

The guideline standardizes the antimicrobial approach to ABRS in Iran, considering local resistance patterns and clinical evidence.

1. Context

Acute bacterial rhinosinusitis (ABRS), defined as inflammation of the paranasal sinuses, manifests in two primary forms: Acute (lasting less than 4 weeks) and chronic (lasting over 12 weeks) (1). The clinical manifestation demonstrates substantial variation, ranging from slight facial pressure and troublesome nasal congestion to more severe facial discomfort, fatigue, and even fevers (1). Sinusitis affects approximately 15% of the population each year, with higher rates observed in women compared to men (2, 3). Research indicates a relatively high frequency of ABRS in Iran, estimated at about 53%. Maxillary sinusitis is the most frequent type. However, there’s a lack of data on the exact incidence of ABRS, which is likely lower than the general sinusitis prevalence (4).

1.1. Risk Factors for Acute Bacterial Rhinosinusitis

Older age, viral upper respiratory tract infections, smoking, flight travel, swimming, exposure to atmospheric pressure variations (including activities like deep-sea diving), allergies and asthma, dental diseases, and immunodeficiency are risk factors for ABRS (5).

1.2. Microbiology

The etiology of sinusitis can be bacterial, viral, or fungal. Most instances of acute sinusitis are viral, especially rhinoviruses. In the order listed, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis are the most often found bacterial species in sinus aspirates from both adults and children (1, 6).

1.3. Scope and Purpose

This Iranian guideline aims to standardize antimicrobial treatment and patient care for ABRS in the general population through evidence-based management strategies. Due to significant regional variations in bacterial etiology, antibiotic resistance patterns, drug availability, healthcare infrastructure, and resource constraints, the need for geographically specific guidelines is emphasized. Overall, these guidelines equip healthcare professionals with the tools to make informed decisions regarding initial empiric antibiotic therapy and subsequent evaluation of infectious etiology in ABRS management.

2. Method

A team of experts from various disciplines reviewed relevant data published between January 1990 and April 2024. This data came from Iranian databases (IranMedex, Irandoc, MagIran) and international sources (Google Scholar, Scopus, PubMed, SID). They also included studies from PubMed to ensure comprehensive coverage. The review focused on studies from Iran that investigated the prevalence, serotype distribution, and antibiotic resistance patterns of key bacterial pathogens involved in ABRS. These pathogens included S. pneumoniae, M. catarrhalis, and H. influenzae. The studies analyzed clinical samples from various sources relevant to ABRS, such as the nasopharynx, ears, eyes, and sinuses. Carrier studies analyzing nasopharyngeal specimens were also included.

The expert panel employed a structured, iterative consensus-building process using a modified Delphi technique: Multidisciplinary specialists (infectious disease specialists and clinical pharmacists) with ≥ 5 years of experience first reviewed evidence from Iranian and international databases to draft preliminary recommendations. Anonymous voting identified areas of disagreement (consensus threshold: ≥ 70% agreement), followed by moderated virtual discussions to reconcile conflicting views, prioritizing local Iranian data (e.g., antibiotic resistance patterns) and grading of recommendations, assessment, development, and evaluation (GRADE) criteria for clinical relevance. Recommendations underwent final anonymous voting, with unresolved items deferred or excluded.

2.1. Grading of Guideline Recommendations

We utilized the GRADE criteria alongside expert opinion to evaluate the evidence for each recommendation (7). The PICO analysis is summarized in Table 1. The definitions for the quality of evidence used in the assessment are detailed in Table 2, and the framework for assigning the strength of recommendation is provided in Table 3.

Table 1.PICO Analysis
Author/YearPopulationNumber of SubjectsIntervention and ControlOutcome MeasuresResultsType of TestStudy MethodologyGRADE Assessment
Amiri et al. (2015), (4)Iranian population with sinusitis1,057Meta-analysis of studiesPrevalence of various types of sinusitisOverall prevalence: 53% (CI 40% - 65%), maxillary: 68%, frontal: 17%, ethmoid: 31%, sphenoid: 19%N. A.Systematic review and meta-analysis1
Hatami et al. (2024), (8)Haemophilus influenzae and Moraxella catarrhalis isolates in Iran189 isolatesSystematic review of antibiotic resistance patternsAntibiotic resistance patterns of H. influenzae and M. catarrhalisH. influenzae: High resistance to ampicillin, M. catarrhalis: High resistance to penicillinN. A.Systematic review2
Khademi and Sahebkar (2021), (9)Streptococcus pneumoniae isolates from Iran1,249 reports from 58 studiesMeta-analysis of studiesPrevalence of penicillin-nonsusceptible and multidrug-resistant S. pneumoniaePNSP: 46.9%, MDR: 45.3%, high resistance to erythromycin, azithromycinN. A.Systematic review and meta-analysis1
Khoramrooz et al. (2012), (10) Iranian children with OME15 centers48 OME patients (63 middle ear fluid samples, 48 adenoid tissues)PCR and bacterial culture methods for pathogen detectionBacterial detection: Alloicoccus otitidis: 23.8% (culture), 36.5% (PCR)-S. pneumoniae: 35.5% (adenoid culture), 31.2% (PCR) antimicrobial susceptibility: Most isolates sensitive to ampicillin, amoxicillin/clavulanate, fluoroquinolonesDisc diffusion methodCross-sectional observational study4
Eghbali et al. (2020), (11)Patients with respiratory tract infections in northern Iran280 patients, 120 controlsIsolation and susceptibility testing of M. catarrhalisPrevalence of M. catarrhalis and antibiotic resistance patternsResistance to penicillin, presence of β-lactamase, various resistance genes detectedDisc diffusion methodObservational study4
Farajzadeh Sheikh et al. (2021), (12)Patients with CAP in southwest Iran92 sputum samplesDetection of S. pneumoniae and H. influenzae using culture and M-PCR methodsDetection rates and antibiotic resistance patterns of S. pneumoniae and H. influenzaeDetection rates (culture): S. pneumoniae: 16.3%; H. influenzae: 7.6%; detection rates (M-PCR): S. pneumoniae: 35.8%; H. influenzae: 11.9%; Antibiotic resistance: S. pneumoniae: 13.3% resistant to ceftriaxone; H. influenzae: 28.6% resistant to clarithromycin, ceftriaxone, gentamicinDisc diffusion methodCross-sectional observational study4
Yousefi et al. (2021), (13)S. pneumoniae isolates in Iran33 studies (total isolates not specified)Systematic review of serotype distribution and resistance patternsFrequency of S. pneumoniae, serotype distribution, and antimicrobial resistance patternsHigh resistance to co-trimoxazole, penicillin, erythromycin, common serotypes: 23F, 19FN. A.Systematic review4
Shokouhi et al. (2019), (14)S. pneumoniae isolates in Iran2,723 cases across 25 studiesReview of macrolide resistance patternsResistance patterns and mechanisms of S. pneumoniae to macrolidesMean macrolide resistance: 48.43%, ermB and mefA mutations prevalentN. A.Narrative review4
Kargar et al. (2014), (15)S. pneumoniae isolates from hospitals in Iran82 isolatesPCR-RFLP analysis of quinolone resistance-determining regionsPresence of mutations in quinolone resistance genes and antibiotic susceptibilityMutation rates: parC: 75.56%, gyrA: 68.89%, high resistance to nalidixic acidDisc diffusion methodObservational study4
Beheshti et al. (2020), (16)S. pneumoniae isolates from clinical samples in Tehran, Iran44 invasive isolatesAnalysis of antibiotic resistance and molecular characterizationResistance patterns, capsular types, and genetic diversity of S. pneumoniaeHigh erythromycin resistance (73%), MDR in penicillin-resistant strains, common types: 6A/B, 19ADisc diffusion methodObservational study4
Mohammadi Gharibani et al. (2019), (17)Healthy children in Ardabil, Iran43 isolatesAnalysis of antibiotic resistance and resistance mechanismsAntibiotic resistance patterns and genetic mechanisms of macrolide resistanceHigh macrolide resistance: Erythromycin 74.4%, genetic: 100% mefA/E, 81.25% ermBE-test strips methodCross-sectional observational study4
Shooraj et al. (2019), (18)Children under 6 years old in Iran328 nasopharynx swabsAnalysis of clonal diversity and antibiotic resistancePrevalence, antibiotic resistance patterns, and clonal diversity of H. influenzae73 strains of H. influenzae, 42% resistance to chloramphenicol, 43% to ampicillin, 28 PFGE patternsDisc diffusion methodCross-sectional observational study4

PICO Analysis

Table 2.Quality of Evidence Definition
Quality of EvidenceDescriptionSource of Evidence
1High confidence that the true effect lies close to that of the estimate of the effect.Evidence from multiple well-conducted RCTs or meta-analyses of RCTs.
2The true effect is likely to be close to the estimate, but there is a possibility that it is different.Evidence from one or more RCTs with limitations or strong evidence from well-designed observational studies.
3The true effect may be substantially different from the estimate.Evidence from well-conducted cohort or case-control studies, or downgraded RCTs with significant limitations.
4The true effect is likely to be substantially different from the estimate.Evidence from observational studies with significant limitations, non-randomized studies, or expert opinion.
5Any estimate of effect is very uncertain.Evidence from unsystematic clinical observations, case reports, or expert opinion without strong supporting data.

Quality of Evidence Definition

Table 3.Strength of Recommendation
Strength of RecommendationDescriptions
A (strong)The benefits of the recommended intervention clearly outweigh the risks. High confidence in its efficacy.
B (moderate)The benefits of the intervention outweigh the risks, but there is less certainty about the balance of benefits and risks.
C (weak/optional)The balance between benefits and risks is uncertain or close, making the recommendation more context-dependent.

Strength of Recommendation

3. Recommendations

3.1. Which Antibiotics are Recommended as First-Line Empiric Therapy for Adults with Uncomplicated Acute Bacterial Rhinosinusitis?

The primary course of treatment for the majority of patients diagnosed with ABRS should consider the significant resistance rates observed in Iran.

- Amoxicillin-clavulanate (500 mg/125 mg orally three times daily or 875 mg/125 mg orally twice daily) is recommended as first-line therapy (1A).

- High-dose amoxicillin-clavulanate (2000 mg/125 mg extended-release tablets orally twice daily) is recommended as first-line therapy in cases where there is a significant concern about antibiotic resistance, particularly due to the high prevalence of penicillin-nonsusceptible S. pneumoniae (2A).

- The administration of β-lactams and/or co-trimoxazole would not have the desired therapeutic effect (3C).

- Monotherapy with clindamycin, 3rd generation cephalosporin, or doxycycline is not recommended (2B).

- Macrolides monotherapy is not recommended for empirical treatment due to high resistance rates among S. pneumoniae and potential methylation and efflux-mediated resistance (2B).

- To overcome resistance to H. influenzae and M. catarrhalis, a macrolide can also be added (3C).

3.2. Which Antibiotic is Recommended for Adults with Uncomplicated Acute Bacterial Rhinosinusitis Who Experience Penicillin Allergy?

- For adults diagnosed with uncomplicated ABRS who have a penicillin allergy, a respiratory fluoroquinolone such as levofloxacin (750 mg or 500 mg orally once daily) or moxifloxacin (400 mg orally once daily) for 5 to 7 days is recommended as an alternative for empiric antimicrobial therapy (3C).

- If an immediate-type hypersensitivity response is confirmed through skin testing, which is strongly advised for patients with a questionable history of penicillin allergy, treatment with respiratory fluoroquinolones is recommended (4C).

- Macrolides and TMP/SMX, previously used for patients allergic to penicillin, are no longer recommended due to increasing resistance among penicillin-nonsusceptible S. pneumoniae (2B).

- If monitoring and facilities for outpatient therapy are accessible, intravenous 3rd generation cephalosporin with close monitoring could be recommended for patients with penicillin intolerance/non-Type I hypersensitivity reactions (3C).

- TMP/SMX and macrolides are not recommended unless the patient is β-lactam allergic due to limited effectiveness against major ABRS pathogens and possible bacterial failure (2B).

3.3. Which Antibiotic is Recommended for Adults with Uncomplicated Acute Bacterial Rhinosinusitis Who Experience Treatment Failure?

- For adults diagnosed with uncomplicated ABRS who experience treatment failure, a change in management is necessary. This is defined as the patient not improving or worsening within 7 days of diagnosis. If there is no response to antimicrobial therapy after 72 hours, either switching to a different antibiotic or re-evaluating the patient is recommended (3C).

- For patients initially managed with observation and later experiencing treatment failure, starting treatment with high-dose amoxicillin with clavulanate is advised (2B).

- Penicillin-allergic patients should consider using a respiratory fluoroquinolone like levofloxacin or moxifloxacin (2B).

- In adults with a history of non-type I hypersensitivity to penicillin, ceftriaxone may be appropriate (3C).

- Fluoroquinolones (levofloxacin or moxifloxacin) should be reserved for cases with known resistance or treatment failure to avoid promoting further resistance (2B).

- If monitoring and facilities for outpatient therapy are accessible, 3rd generation cephalosporin with close monitoring could be recommended (4C).

- For patients who do not respond to initial treatment, initiating therapy with cefixime and clindamycin is recommended (4C).

4. Summary of Evidence

In Iran, S. pneumoniae exhibits varying levels of antibiotic resistance, including resistance to amoxicillin. Studies indicate a high prevalence of penicillin-nonsusceptible S. pneumoniae (PNSP) strains, with amoxicillin resistance rates reaching 30.5% (9). Living in regions where PNSP rates exceed 10% poses a significant risk factor for pneumococcal resistance (19). Additionally, due to the production of β-lactamase by M. catarrhalis and H. influenzae, amoxicillin proves ineffective against these pathogens, thus it is not recommended as a first-line therapy in Iran. In line with regional trends, high rates of amoxicillin resistance have been observed in M. catarrhalis isolates, with studies reporting resistance rates of 100% and 81.2% (10, 11). These findings suggest amoxicillin may not be a suitable first-line therapy for M. catarrhalis infections. While the prevalence of β-lactamase-producing H. influenzae in the United States ranges from 27% to 43% and is not expected to respond to amoxicillin without clavulanate (20), resistance to amoxicillin-clavulanate is very high in Iran; specifically, the antibiotic resistance to amoxicillin-clavulanate for H. influenzae in patients with community-acquired pneumonia is around 85.7%. However, this resistance rate cannot be extrapolated to patients with ABRS (12). In Iran, studies have extensively investigated the resistance patterns of S. pneumoniae to various antibiotics, but there is no specific mention of amoxicillin-clavulanate resistance in the provided contexts. Among respiratory pathogens in Iran, ceftriaxone demonstrated the most favorable resistance profile, with resistance rates of 13.3% for S. pneumoniae, 28.6% for H. influenzae, and 6.2% for M. catarrhalis isolates (8, 12, 13). Consistent with prior reports of geographically variable macrolide resistance (10% - 100%), one analysis of 25 studies (n = 2723) identified a mean resistance rate of 48.43% (CI, 38.8 - 57.9%) (14); additionally, macrolides showed efficacy against both H. influenzae and M. catarrhalis isolates, highlighting their potential as effective therapeutic options (8). Fluoroquinolone resistance in S. pneumoniae is a concerning issue in Iran, as studies have shown a significant correlation between quinolone resistance development and mutations in the parE, parC, and gyrA genes (15). Studies conducted in Iran have demonstrated heterogeneity in ciprofloxacin susceptibility among respiratory pathogens. Streptococcus pneumoniae exhibits the lowest resistance rates (0 - 11%), whereas M. catarrhalis (0 - 70%) and H. influenzae (0 - 57.1%) display a wider range of susceptibility (8, 11, 12, 21). Studies investigating levofloxacin resistance in S. pneumoniae from Iran have documented regional variations. Research in Tehran found a low prevalence (2%) of levofloxacin-resistant invasive S. pneumoniae isolates (16). Further supporting this trend, a separate cross-sectional study involving 43 isolates of S. pneumoniae from healthy children in Ardabil reported no resistance to levofloxacin (17). Similarly, studies evaluating fluoroquinolone susceptibility among respiratory pathogens, including M. catarrhalis and H. influenzae, observed a 0% resistance rate to levofloxacin (10, 12, 18). These findings collectively suggest potentially low levels of levofloxacin resistance in S. pneumoniae and some other respiratory bacteria associated with ABRS in Iran. Furthermore, levofloxacin resistance in Iranian children was found to be 0.8% and 1.7% for S. pneumoniae, respectively, based on a subgroup analysis of 27 studies (9). In a cross-sectional study conducted in Ardabil, antibiotic resistance profiles of 43 S. pneumoniae isolates from healthy children were determined using the disk diffusion method. Clindamycin resistance was identified in 28% of isolates, with no evidence of inducible resistance (17). Unfortunately, direct assessment of doxycycline resistance among S. pneumonia in Iran remains a topic for future investigation.

5. Research Needed in Iran

There is a notable scarcity of head-to-head randomized clinical trials and robust evidence concerning the management of patients with ABRS. Additionally, there is a pressing need for clinical trials that juxtapose different antimicrobial treatment protocols for outpatient settings. These trials should thoroughly evaluate the occurrence of adverse effects associated with antibiotics. It is imperative to disseminate the findings of antibiograms featuring broad-spectrum antibiotics and to gauge the prevalence of particular pathogens to enhance the detection of antimicrobial susceptibility. Moreover, research into the antimicrobial resistance of antibiotics like clindamycin and doxycycline against ABRS pathogens is scarce and should be explored.

Acknowledgments

Footnotes

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