A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis (WINGS-4-FGS)
A Phase III, Randomised, Open-Label, Parallel-Group, Controlled Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs (Diclofenac and Prednisolone) in Addition to Praziquantel in Girls and Women (15-49 Years Old) With Female Genital Schistosomiasis
Female Genital Schistosomiasis (FGS) is a neglected complication of Schistosoma haematobium infection affecting an estimated 56 million women and girls globally, with a high burden in sub-Saharan Africa. Up to 75% of infected women develop genital lesions, often without being aware of their condition. FGS causes chronic genital and urinary symptoms, overlaps clinically with sexually transmitted infections, and increases the risk of HIV acquisition by 2-4 times. FGS remains widely underdiagnosed due to limited healthcare provider training, stigma, and lack of affordable diagnostic tools in resource-limited settings. Current control strategies rely on mass drug administration of praziquantel (PZQ) targeting school-aged children and adults in high risk or endemic communities, which neither adequately reaches affected women nor addresses established genital morbidity. PZQ eliminates adult worms but does not reverse chronic inflammation or granulomas caused by trapped eggs, and no clinical guidelines exist for managing FGS-related morbidity. Given these gaps, there is an urgent need to evaluate additional, locally available treatments in combination with praziquantel to reduce inflammation, improve morbidity outcomes, and inform effective clinical management of FGS.
This trial is funded by Global Health EDCTP3 and sponsored by KUHeS, INRB, UFHB, and UHAS. This Phase III, open label, 4x2 factorial superiority randomized controlled trial will take place in multiple schistosomiasis endemic countries in sub-Saharan Africa, among women living with schistosomiasis, testing already registered anti-inflammatory drugs (prednisolone, diclofenac). Each arm shall have at least 100 participants, who shall be followed up at 3-, 6-, and 12-month post first IP administration.
The trial will recruit 800 girls and women of reproductive age (15- 49 years) at 4 sites (Malawi, Ghana, Democratic Republic of Congo, and Cote d'Ivoire), with each site aiming to recruit 200 participants (25 per site per treatment arm).
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Janelisa Professor
- 电话号码：+265884595095
- 邮箱：jmusaya@mlw.mw
学习地点
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Kimpese、刚果民主共和国
- Kimpese
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接触：
- Dieudonne Professor
- 电话号码：+265884595095
- 邮箱：mumbadiedonne@yahoo.fr
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Ho、加纳
- Asuogyaman
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接触：
- Wisdom Professor
- 电话号码：+233244940594
- 邮箱：wazanu@uhas.edu.gh
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Abidjan、科特迪瓦
- Bouafle and Zuenoula
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接触：
- Mamadou Doctor
- 电话号码：+265884595095
- 邮箱：mamadou_ouatt@yahoo.fr
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Mangochi、马拉维
- Mangochi DHO
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接触：
- Jenalisa Professor
- 电话号码：+265884595095
- 邮箱：jmusaya@mlw.mw
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed written Informed Consent by Participant and assent for minor participants.
- Girls and women aged 15- 49 years.
- Weight ≥ 35kgs (only in the applicable countries due to Diclofenac prescription limitation)
- Girls and women must have had their sexual debut.
- Agreed to have a gynecological exam including colposcopy, provide a cervicovaginal swab and lavage, urine, stool, and a venous sample.
- Confirmed case of FGS: (a) self-reporting symptoms AND (b) parasitological/antigen confirmation of Schistosoma infection (Egg positivity) AND (c) DNA positivity from genital samples AND (d) FGS pathognomonic lesions from colposcopy.
- Acceptance of the requirement to use a barrier form of birth control (e.g. condoms) or other effective contraceptive method effective from Day 1 until Day 57 or documented permanent infertility or postmenopausal status.
Exclusion Criteria:
- Pregnant women.
- Gynecological or any other type of cancer.
- Presence of abnormal physical findings or laboratory values at screening (e.g. severe anaemia) that could interfere with the objectives of the trial or the safety of the subject, in the opinion of the Investigator.
- Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being of the participant), or that could prevent, limit, or confound the protocol specified assessments.
- Treatment with PZQ or drugs with known anti-schistosomal effect within the last 3 months.
- History or presence of gastro-duodenal ulcers or hematemesis, signs, or symptoms of gastritis.
- Contraindication to any of the study drugs, as stated in the approved Reference Safety Information (SmPC).
- Living less than one year in the community.
- Known allergy to the drugs or any of their ingredients used in the trial.
- Current enrolment or past participation in another investigational trial in which an investigational intervention (e.g. drug, vaccine, invasive devise) was administered within 30 days or 5 half-lives (whichever is the longest) before first dose of trial drug (to be adjusted as per country-specific regulation).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Praziquantel 40
Praziquantel 40 given on day 1, day 28 and day 56 |
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实验性的：Praziquantel 80
Praziquantel 80 given on day 1, day 28 and day 56 |
Praziquantel 80mg (High dose) compared to 40mg SoC |
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实验性的：Praziquantel 40 plus Prednisolone 5d
Praziquantel 40 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 |
5 days Prednisolone 20mg given with Praziquantel 40mg |
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实验性的：Praziquantel 80 plus Prednisolone 5d
Praziquantel 80 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 |
Prednisolone 20mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. |
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实验性的：Praziquantel 40 plus Diclofenac 5d
Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 |
5 days Diclofenac given with Praziquantel 40mg 15 days Diclofenac given with Praziquantel 40mg |
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实验性的：Praziquantel 80 plus Diclofenac 5d
Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 |
Diclofenac 75mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. |
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实验性的：Praziquantel 40 plus Diclofenac 15d
Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 |
5 days Diclofenac given with Praziquantel 40mg 15 days Diclofenac given with Praziquantel 40mg |
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实验性的：Praziquantel 80 plus Diclofenac 15d
Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 |
Diclofenac 75mg from day 1 to day 15 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in pathognomonic sign(s) in the cervix from baseline to month 3.
大体时间：3 months
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Improvement in pathognomonic sign(s) in the cervix from baseline to month 3 (binary outcome of improvement vs no improvement) from cervical assessments only using Female Genital Schistosomiasis lesion indicators; grainy sandy patches, homogenous yellow patches and rubbery papules. |
3 months
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Improvement (reduction) in urogenital frequency symptom score from baseline to month 3.
大体时间：3 months
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Improvement (reduction) in urogenital (gynaecological) frequency symptom score on a 0-4 scale, calculated as sum total of eight symptom components; lower abdominal pain, dysuria, vulvovaginal itching, abnormal vaginal discharge, menstrual disturbances, intermenstrual bleeding, dyspareunia and bleeding during or after intercourse, from baseline to month 3 (continuous outcome). Higher scores will indicate greater symptom burden. |
3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Effect of anti-inflammatory and Praziquantel dose on overall clinical improvement in women with FGS
大体时间：12 months
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Assessing improvement in pathognomonic sign(s) in the cervix by FGS lesion indicators and urogenital (gynaecological) overall symptom score from baseline to months 3 (PZQ dose comparison only), 6 and 12. |
12 months
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Effect of anti-inflammatory and Praziquantel dose on parasitological improvement in women with Female Genital Schistosomiasis.
大体时间：12 months
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Assessed by measuring; Antigen (Circulating Anodic Antigen) concentration in urine at day 28, day 56 and month 3, 6, 12, total egg count by urine filtration at days 28 and 56 and months 3, 6, 12, and the absence of schistosome DNA in cervicovaginal swabs at months 3, 6, 12. |
12 months
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Safety and tolerability of anti-inflammatory and Praziquantel treatment in women with Female Genital Schistosomiasis
大体时间：12 months
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Assessing the safety and tolerability of trial treatments by occurrence of treatment emergent adverse events (TEAE) in all arms categorized as; non-serious TEAEs up to day 57, serious adverse events (SAEs) up to day 57, TEAE leading to discontinuation of treatment up to day 57, TEAE leading to trial withdrawal up to day 57, Fatal SAE up to month 12, and TEAE reported as related to trial drugs up to month 12. |
12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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