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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Centers for Disease Control and Prevention | FED |
| Kwame Nkrumah University of Science and Technology | OTHER |
| Barcelona Institute for Global Health |
The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. Patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The follow-up period of patients will be 6 months. Assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. The primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZT30 | Active Comparator | Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams |
|
| AZT20 | Experimental | Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Comparison of two different dosing strategies for the treatment of yaws |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical and Serological Cure | Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical and Serological Cure in Latent Yaws | Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-negative. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mabey | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School Based Recruitment | Ayensuanor District | Eastern Region | Ghana | |||
| School Based Recruitment |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29456191 | Derived | Marks M, Mitja O, Bottomley C, Kwakye C, Houinei W, Bauri M, Adwere P, Abdulai AA, Dua F, Boateng L, Wangi J, Ohene SA, Wangnapi R, Simpson SV, Miag H, Addo KK, Basing LA, Danavall D, Chi KH, Pillay A, Ballard R, Solomon AW, Chen CY, Bieb SV, Adu-Sarkodie Y, Mabey DCW, Asiedu K; study team. Comparative efficacy of low-dose versus standard-dose azithromycin for patients with yaws: a randomised non-inferiority trial in Ghana and Papua New Guinea. Lancet Glob Health. 2018 Apr;6(4):e401-e410. doi: 10.1016/S2214-109X(18)30023-8. Epub 2018 Feb 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZT30 | Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws |
| FG001 | AZT20 | Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZT30 | Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws |
| BG001 | AZT20 | Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical and Serological Cure | Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws. | Posted | Count of Participants | Participants | 6 Months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZT30 | Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Marks | London School of Hygiene and Tropical Medicine | +447984643424 | michael.marks@lshtm.ac.uk |
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| ID | Term |
|---|---|
| D015001 | Yaws |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| OTHER |
| Papua New Guinea Institute of Medical Research | OTHER_GOV |
| Ghana Health Services | OTHER_GOV |
| Noguchi Memorial Institute for Medical Research | OTHER |
| Papua New Guinea National Department of Health | UNKNOWN |
| University of Health and Allied Sciences | OTHER |
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| Number of Participants With Adverse Events |
To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens |
| 6 months |
| Upper West Akyem |
| Eastern Region |
| Ghana |
| School Based Recruitment | West Akyem District | Eastern Region | Ghana |
| School Based Recruitment | Nkwanta North District | Volta Region | Ghana |
| Community Based Recruitment | Karkar District | Madang Province | Papua New Guinea |
| Community Based Recruitment | Kavieng Subdistrict | New Ireland Province | Papua New Guinea |
| London School of Hygiene and Tropical Medicine | London | WC1E 7HT | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Clinical and Serological Cure in Latent Yaws | Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-negative. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| Secondary | Number of Participants With Adverse Events | To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 291 |
| 12 |
| 291 |
| EG001 | AZT20 | Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws | 0 | 292 | 15 | 292 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Organic Chemicals |