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Horton, Jennifer, MD, University of Utah, Primary Children’s Hospital. 

Articles

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Can you diagnose this 10-year-old with an oozy ear? 

Full case: Don’t turn a blind eye to an oozy ear 

. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

A pair of phase 3 trials showed that AbbVie's daily upadacitinib 15 mg led to a 50% reduction in T-VASI 50 and a 75% reduction in F-VASI 75 at 48 weeks among adolescents 12 years and older.

Upadacitinib achieves 50% reduction in Total Vitiligo Area Scoring Index at 48 weeks

Tracey Gaslin, PhD, CPNP, FNP-BC, CRNI, RN-BC, CEO, Alliance for Camp Health.

In this Q&A, nurse practitioner Tracey Gaslin, PhD, discusses tick bites in pediatric patients, from how to prevent a bite to what to do after a bite, and highlights resources available from the Fight the Bite initiative.

Talking ticks with Tracey Gaslin, PhD, CPNP, FNP-BC, CRNI, RN-BC

Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN, shares her thoughts on a featured article from the October 2025 issue of Contemporary Pediatrics.

Screening for suicide ideation and suicide attempts is a priority

Contemporary Pediatrics connects pediatricians with peer-reviewed articles, guideline updates, and practice strategies for real-world clinical application.

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A 14-year-old girl presented with concerns about a "deformed" right shoulder. Despite the fact that there was no associated weakness, the defect made her self-conscious. She denied recent trauma to the site and severe physical exertion.

Photoclinic: Winged Scapula

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

New subgroup analyses from the global phase 3 zoliflodacin trial highlight the drug’s efficacy against multidrug-resistant 

, including ciprofloxacin-resistant strains, across all infection sites and patient subgroups. The data were presented at 

Zoliflodacin (ZFD) is a first-in-class spiropyrimidinetrione gyrase inhibitor with a novel mechanism of action designed to overcome growing gonococcal resistance to existing therapies. In the pivotal phase 3 randomized controlled trial (NCT03959527), a single oral dose of ZFD demonstrated noninferiority to the current dual therapy standard—ceftriaxone plus azithromycin—for uncomplicated urogenital gonorrhea. Cure rates for pharyngeal and rectal infections were also comparable between treatment arms.

According to ClinicalTrials.gov, the trial featured patients aged 12 years and older, who weighed at least 35 kg, with signs and symptoms consistent with

Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture, NAAT, Gram stain, or methylene blue test/gentian violet stain in the past 14 days prior to screening  

Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain, or methylene blue test/ gentian violet stain or culture)

Zoliflodacin was granted Priority Review by the FDA on June 12, 2025, and was assigned a target action date of December 15, 2025.

Consistent results across MIC levels and resistance profiles

The new subgroup findings examined microbiological cure rates by baseline ZFD minimum inhibitory concentration (MIC) and ciprofloxacin (CIP) susceptibility. Among evaluable participants, baseline isolates had ZFD MICs ranging from ≤ 0.008 to 0.5 µg/mL. High microbiological cure rates were achieved for isolates with ZFD MICs ≤ 0.25 µg/mL—the range covering nearly all samples in the study. There were too few isolates at 0.5 µg/mL (n = 3) to draw conclusions about response at that level.

Strong outcomes across sites of infection

Microbiological cure rates at urogenital sites of infection were 96.6% among participants infected with CIP-resistant 

 and 97.4% among those with CIP-susceptible baseline 

. High rates of microbiological cure for CIP-resistant 

 were maintained for pharyngeal and rectal sites of infection, geographical location, and sex at birth.

Microbiological cure rates ≥ 91% across urogenital, rectal, and pharyngeal sites of infection for participants in the evaluable population.

Microbiological cure consistent in both ciprofloxacin-resistant and -susceptible infections

ZFD MICs ≤ 0.25 µg/mL associated with high response rates

No difference in outcomes by geography or sex assigned at birth

These results support zoliflodacin’s potential as an effective single-dose oral therapy—an important advantage for improving access, adherence, and treatment completion compared with injectable regimens. Study authors also note zoliflodacin’s stable potency across years of surveillance, further supporting its long-term potential against resistant 

Sarah McLeod, PhD, senior director of Clinical Microbiology at Innoviva Specialty Therapeutics, discussed these findings and their clinical implications in a Q&A that follows.

Q&A with Sarah McLeod, PhD, on zoliflodacin data for uncomplicated gonorrhea

The subgroup data showed high cure rates across infection sites and resistance profiles. What do these findings tell us about how zoliflodacin performs against resistant 

The rationale for evaluating zoliflodacin in this phase 3 study stems from the urgent global need for new antibiotics to treat gonorrhea, particularly in the face of rising antimicrobial resistance (AMR).

 has developed resistance to every class of antibiotics historically used to treat it, and treatment options are becoming increasingly limited. 

The phase 3 subset analysis presented at IDWeek highlighted high microbiological cure rates with zoliflodacin across urogenital, rectal, and pharyngeal sites, including against ciprofloxacin-resistant 

strains. Among participants with urogenital infections, cure rates were 96.6% for ciprofloxacin-resistant and 97.4% for ciprofloxacin-susceptible strains. 

These results were consistent across infection sites and resistance profiles. Zoliflodacin is a first-in-class spiropyrimidinetrione antibiotic with a novel mechanism of action, distinct from currently available therapies. The data reinforce zoliflodacin’s potential as a single-dose oral treatment for uncomplicated gonorrhea, particularly in the face of rising resistance to current therapies.

Zoliflodacin MIC values were consistent across patient groups. Why is that uniform activity important, and what could it mean for real-world use?

Zoliflodacin maintained in vitro activity across isolates from diverse patient groups, including women, men who have sex with men, and heterosexual men, regardless of baseline resistance to other antibiotics, reinforcing its potential as a single-dose oral treatment for uncomplicated gonorrhea.

The consistency of cure rates across demographics, including female participants, underscores zoliflodacin’s potential as a treatment option in the face of rising antibiotic resistance.

These findings have important real-world implications, especially for women. Gonorrhea can often be asymptomatic in women but still lead to serious complications like pelvic inflammatory disease, infertility, and adverse pregnancy outcomes.

Surveillance data show zoliflodacin’s potency has remained stable over several years. How confident are you that this durability will hold once the drug is in broader clinical use?

 continues to evolve resistance to nearly every antibiotic used against it, especially in parts of Asia and Africa, and we are starting to see resistance in parts of the United States. This pathogen is one of the most urgent threats identified by global health authorities, including the CDC and WHO, because of its ability to rapidly develop and spread resistance.

Without new treatment options, we risk returning to an era where gonorrhea could become increasingly difficult to effectively treat, leading to severe reproductive health complications, adverse pregnancy outcomes, and increased HIV transmission.

What makes this Phase 3 trial particularly important is that it evaluates zoliflodacin, a novel, first-in-class antibiotic with a different mechanism of action from current therapies. The trial was also designed and conducted with a global perspective, including sites in the United States, Belgium, the Netherlands, Thailand, and South Africa. Many of these countries have high burdens of drug-resistant gonorrhea.

The data generated from the Phase 3 study highlight the clinical potential of zoliflodacin and provide valuable insights for both clinical practice and public health strategies aimed at controlling the spread of resistant strains.
In the foreseeable future, we anticipate significant advancements in pathogen-targeted and precision antimicrobial therapies. The traditional 1-size-fits-all approach is being replaced by more specific and effective therapies that support antimicrobial stewardship, preserve the microbiome, and potentially help slow down the development of resistance.

This innovation will be supported by rapid diagnostic tools that allow for earlier and more targeted treatments, as well as new therapeutic modalities. Additionally, the development of sustainable models that include public-private partnerships, targeted commercialization, and responsible financing frameworks will be crucial for bringing new antibiotics to the market.

The phase 3 trial met non-inferiority to ceftriaxone plus azithromycin. From a clinical standpoint, what advantages does a single-dose oral therapy offer over the current injectable standard?

In the pivotal Phase 3 trial, a multinational, randomized, controlled, open-label, non-inferiority trial, zoliflodacin demonstrated non-inferiority to the current standard dual therapy of ceftriaxone plus azithromycin for the treatment of uncomplicated urogenital gonorrhea, with both regimens showing comparable safety profiles.

The not-for-profit organization Global Antibiotic Research & Development Partnership (GARDP) sponsored the study with support from Innoviva Specialty Therapeutics A total of 930 adolescent and adult participants were enrolled across 16 sites in 5 countries with high gonorrhea prevalence, making it the largest clinical trial to date for a new treatment targeting 

Participants received either a single, 3g oral dose of zoliflodacin or the standard regimen of 500mg intramuscular ceftriaxone plus 1g oral azithromycin. Zoliflodacin met the prespecified criteria for non-inferiority, with a treatment difference of 5.31% (95% CI: 1.38%, 8.65%) for microbiological cure of urogenital infection. It was generally well-tolerated, with adverse events comparable across both treatment groups, and no serious adverse events were reported.

Having a new, single-dose oral treatment shown to be effective across all anatomical sites and resistant strains has the potential to simplify treatment and improve adherence, particularly in settings where follow-up may be difficult.

For OB/GYNs, this represents a promising step toward more accessible and effective care for women affected by gonorrhea. 

cUTI Roundtable: Discussing and diagnosing these difficult infections

This series looks to discuss several topics around these infections including diagnosis and treatment.

McLeod S, Bettiol E, Elango V, et al. Subgroup Analyses of Microbiological Cure Rates by Baseline Zoliflodacin MIC and Susceptibility to Ciprofloxacin in Participants from the Global Zoliflodacin Phase 3 Randomized Controlled Trial. Oral Abstract. Presented at IDWeek 2025. October 19-22, 2025. Atlanta, GA. 

Zoliflodacin in uncomplicated gonorrhoea. ClinicalTrials.gov. Updated October 8, 2025. Accessed October 27, 2025. https://www.clinicaltrials.gov/study/NCT03959527 

FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhea and assigns target PDUFA date of December 15, 2025. Innoviva Specialty Therapeutics. Press release. Published June 12, 2025. Accessed October 27, 2025. https://investor.inva.com/news-releases/news-release-details/fda-grants-priority-review-zoliflodacin-new-drug-application

Zoliflodacin study investigator Sarah McLeod, PhD, highlights data presented at IDWeek 2025 in this Q&A with Contemporary Pediatrics.

Tracy Weimer, MD

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