FeverPhase 3NCT02595827
Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo
A Phase 3 study testing Conditional Advice in people with Fever, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
Trial summary
Providers in integrated Community Case Management (iCCM) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. These children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. Read more about this study
- Who is it for?
- Ages 2 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Conditional Advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,451 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 9 Oct 2015to 5 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Agree to recruitment script provided by CHWs at the time of identification of eligible
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
International Rescue Committee, Kalemie Office
Kalemie, Katanga
About this study
Official title: Universal Versus Conditional Follow Up for Children With Unclassified Fever at the Community Level: A Cluster-Randomized, Community-based, Non-Inferiority Trial in Kalemie, Democratic Republic of Congo (DRC)
Providers in integrated Community Case Management (iCCM) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. These children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if conditional return advice (i.e. return in 2 or 3 day only if your child is still sick") results in the same proportion of children remaining with fever one week after identification, as the current universal return advice.
Read the detailed description
Fevers in childhood are common and usually self resolve. In rural Democratic Republic of Congo (and many other settings), when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to World Health Organization (WHO) guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the CHW provides an antipyretic only, sends the child home, and advises all such cases to come back in 3 days. We hypothesize, however, that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days, only if symptoms have not resolved.
To test this hypothesis, we are conducting a cluster-randomized, community-based non-inferiority trial in two zones of Kalemie, Katanga Province, Democratic Republic of Congo. In this area, the International Rescue Committee (IRC) has been supporting the training, scale-up, and rollout of community health workers who conduct iCCM as per WHO guidelines and with Ministry of Health oversight. CHWs have unique non-overlapping catchment areas, and groups of CHWs (average 5-7) are associated with health clinics. We will utilize this group structure as the unit of randomization; health clinics (and thereby, groups of CHWs) will be randomly allocated to one of two groups in terms of the advice given to caretakers of children who have no danger signs, have neither malaria, pneumonia, nor diarrhea, and are thus classified as having fever of non-identified origin.
- Group 1 (Universal follow-up): CHWs in this group will advise caretakers to follow up in 3 days
- Group 2 (Conditional follow-up): CHWs in this group will advise caretakers to follow up in 3 days if symptoms/signs remain the same (or worsen).
- Conditions
- Fever
- Being tested
- Conditional Advice
- Keywords
- Pediatrics, Epidemiology, Fever, Democratic Republic of the Congo, Randomized Controlled Trial
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional AdviceOther
Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.
| Study group | Role | What they receive |
|---|---|---|
| Universal | No intervention | In this group, caretakers of children will receive the standard advice under current iCCM guidelines in DRC. Specifically, the CHW will advise that the child come back in 2-3 days. |
| Conditional | Active comparator | In this Conditional Advice group, caretakers will be given advice that is modified from the current iCCM guidelines. Specifically, the CHW will advise that the child come back in 2-3 days if the child's symptoms continue. Receives: Other: Conditional Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure at 7 days
If the child has fever, has a CHW-treatable condition (pneumonia, malaria, or diarrhea), or is referred for care at the Day 7 visit, the child has met the definition of the primary outcome
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start9 Oct 2015
- Primary completion5 Dec 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- International Rescue Committee, University Research Co, LLC, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Luke C Mullany, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595827
- Sponsor's protocol ID
- 68295
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mullany LC, van Boetzelaer EW, Gutman JR, Steinhardt LC, Ngoy P, Barbera Lainez Y, Wittcoff A, Harvey SA, Ho LS. Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in the Democratic Republic of the Congo: A cluster-randomized, community-based non-inferiority trial. PLoS Med. 2018 Apr 17;15(4):e1002552. doi: 10.1371/journal.pmed.1002552. eCollection 2018 Apr.
PubMed 29664951van Boetzelaer E, Ho LS, Gutman JR, Steinhardt LC, Wittcoff A, Barbera Y, Ngoy P, Harvey SA, Mullany LC. Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level: design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo. BMC Pediatr. 2017 Jan 26;17(1):36. doi: 10.1186/s12887-017-0792-1.
PubMed 28122542
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Versus Conditional Follow Up for Children With Unclassified Fever at the Community Level: A Cluster-Randomized, Community-based, Non-Inferiority Trial in Kalemie, Democratic Republic of Congo (DRC)
- ClinicalTrials.gov ID
- NCT02595827
- Acronym / sponsor ID
- 68295
- Conditions
- Fever
- Keywords
- Pediatrics, Epidemiology, Fever, Democratic Republic of the Congo, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,451 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- International Rescue Committee, University Research Co, LLC, Centers for Disease Control and Prevention
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Providers in integrated Community Case Management (iCCM) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. These children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if conditional return advice (i.e. return in 2 or 3 day only if your child is still sick") results in the same proportion of children remaining with fever one week after identification, as the current universal return advice.
Detailed description
Fevers in childhood are common and usually self resolve. In rural Democratic Republic of Congo (and many other settings), when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to World Health Organization (WHO) guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the CHW provides an antipyretic only, sends the child home, and advises all such cases to come back in 3 days. We hypothesize, however, that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days, only if symptoms have not resolved.
To test this hypothesis, we are conducting a cluster-randomized, community-based non-inferiority trial in two zones of Kalemie, Katanga Province, Democratic Republic of Congo. In this area, the International Rescue Committee (IRC) has been supporting the training, scale-up, and rollout of community health workers who conduct iCCM as per WHO guidelines and with Ministry of Health oversight. CHWs have unique non-overlapping catchment areas, and groups of CHWs (average 5-7) are associated with health clinics. We will utilize this group structure as the unit of randomization; health clinics (and thereby, groups of CHWs) will be randomly allocated to one of two groups in terms of the advice given to caretakers of children who have no danger signs, have neither malaria, pneumonia, nor diarrhea, and are thus classified as having fever of non-identified origin.
- Group 1 (Universal follow-up): CHWs in this group will advise caretakers to follow up in 3 days
- Group 2 (Conditional follow-up): CHWs in this group will advise caretakers to follow up in 3 days if symptoms/signs remain the same (or worsen).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal | No intervention | –In this group, caretakers of children will receive the standard advice under current iCCM guidelines in DRC. Specifically, the CHW will advise that the child come back in 2-3 days. |
| Conditional | Active comparator | Other: Conditional AdviceIn this Conditional Advice group, caretakers will be given advice that is modified from the current iCCM guidelines. Specifically, the CHW will advise that the child come back in 2-3 days if the child's symptoms continue. |
Who may qualify
- Ages
- 2 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Agree to recruitment script provided by CHWs at the time of identification of eligible
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional AdviceCaretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue. | Other | Conditional |
Primary outcome
Clinical failure at 7 days
Time frame: 1 week
If the child has fever, has a CHW-treatable condition (pneumonia, malaria, or diarrhea), or is referred for care at the Day 7 visit, the child has met the definition of the primary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 29664951Mullany LC, van Boetzelaer EW, Gutman JR, Steinhardt LC, Ngoy P, Barbera Lainez Y, Wittcoff A, Harvey SA, Ho LS. Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in the Democratic Republic of the Congo: A cluster-randomized, community-based non-inferiority trial. PLoS Med. 2018 Apr 17;15(4):e1002552. doi: 10.1371/journal.pmed.1002552. eCollection 2018 Apr.
- Derived from this study: PubMed 28122542van Boetzelaer E, Ho LS, Gutman JR, Steinhardt LC, Wittcoff A, Barbera Y, Ngoy P, Harvey SA, Mullany LC. Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level: design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo. BMC Pediatr. 2017 Jan 26;17(1):36. doi: 10.1186/s12887-017-0792-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke C Mullany, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conditional Advice in people with Fever, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical failure at 7 days (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.