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).
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Janelisa Professor
- 電話番号：+265884595095
- メール：jmusaya@mlw.mw
研究場所
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Ho、ガーナ
- Asuogyaman
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コンタクト：
- Wisdom Professor
- 電話番号：+233244940594
- メール：wazanu@uhas.edu.gh
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Kimpese、コンゴ民主共和国
- Kimpese
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コンタクト：
- Dieudonne Professor
- 電話番号：+265884595095
- メール：mumbadiedonne@yahoo.fr
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Abidjan、コートジボワール
- Bouafle and Zuenoula
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コンタクト：
- Mamadou Doctor
- 電話番号：+265884595095
- メール：mamadou_ouatt@yahoo.fr
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Mangochi、マラウイ
- Mangochi DHO
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コンタクト：
- Jenalisa Professor
- 電話番号：+265884595095
- メール：jmusaya@mlw.mw
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Praziquantel 40
Praziquantel 40 given on day 1, day 28 and day 56 |
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実験的：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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実験的：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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実験的：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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実験的：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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実験的：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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実験的：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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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Improvement in pathognomonic sign(s) in the cervix from baseline to month 3.
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effect of anti-inflammatory and Praziquantel dose on overall clinical improvement in women with FGS
時間枠：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.
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FGS-DPP-01
- 101190584 (その他の助成金/資金番号：EDCTP3)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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